2013-06-26 22:07:01 -
FDA Classifies Notifications
MINNEAPOLIS - June 26, 2013 - In June 2013, Medtronic, Inc. (NYSE: MDT)
initiated four medical device notifications to customers worldwide about the
SynchroMed® Implantable Infusion System. These notifications provide clinicians
with information to help identify and manage issues that impact the safe and
reliable delivery of therapy using the SynchroMed Implantable Infusion System.
The United States Food and Drug Administration (FDA) has classified three of
these notifications as Class I recalls.The fourth notification is an update to a
2011 action related to pump refill which was previously classified by the FDA as
a Class I recall.
Patients are encouraged to maintain regular follow-up appointments with their
physicians; however, if they experience a change or return of symptoms or hear a
device alarm, they should contact their physician immediately.
No action is
required of physicians beyond the recommendations provided in the notifications.
Medtronic's intrathecal drug delivery systems are used to treat chronic,
intractable pain and severe spasticity of cerebral or spinal origin. These
notifications do not involve Medtronic external insulin pumps for diabetes.
Specifically, the Neuromodulation business of Medtronic has initiated the
following field corrective actions:
SynchroMed Implantable Infusion Pump Priming Bolus Medtronic has issued
an Urgent Medical Device Correction notification which provides
physicians with important safety information and patient management
recommendations regarding the SynchroMed Implantable Infusion System
priming bolus function. The FDA has classified this notification as a
Class I recall.
The priming bolus function is used to quickly move drug from the
SynchroMed pump reservoir to the catheter tip to initiate intrathecal
drug delivery therapy while a patient remains under medical supervision.
Medtronic has found that any time the priming bolus is used with a
SynchroMed pump, drug mixes with the sterile water or cerebrospinal
fluid already in the catheter. This mixing results in the unintended
delivery of drug prior to the end of the programmed bolus, as well as
dilution of some of the drug remaining in the catheter at the end of the
bolus. This can contribute to an increased risk of adverse events
involving drug overdose or underdose following an initial system implant
or revision.The effects of a drug overdose or underdose will vary
depending on the drug being infused but may include, for example, a
reduced level of consciousness or a return of underlying symptoms.
Medtronic recommends healthcare professionals continue using the priming
bolus procedure to ensure therapy is initiated while a patient is under
medical supervision. Recommendations are being provided for performing a
priming bolus, monitoring patients post implant, and educating patients
and caregivers. Medtronic continues to investigate factors related to
this issue to determine appropriate product updates.
SynchroMed Implantable Infusion Pump Shorting
Medtronic has issued an Urgent Medical Device Correction notification to
inform physicians about the potential for an electrical short within the
SynchroMed pump. The FDA has classified this notification as a Class I
An electrical short could lead to pump motor stall and a subsequent loss
of or reduction in therapy, which can result in the return of underlying
symptoms and/or withdrawal symptoms. The SynchroMed II pump is equipped
with alarms designed to alert the patient in the event of a motor stall.
Medtronic encourages patients to contact their physicians immediately if
they experience a return of symptoms or hear a device alarm. The
cumulative failure rate due to this issue is less than one percent at
seven years post implant. Because of the estimated low occurrence rate,
the alarm safety feature and the risks associated with replacement
surgery, Medtronic is not recommending removal of the devices unless a
patient's pump shows signs of a malfunction. Medtronic is in the process
of developing design updates to mitigate this issue.
SC Intrathecal Catheter Product Removal
Medtronic has redesigned its Sutureless Connector (SC) Catheter to
reduce the potential for occlusion, which is the blockage or cessation
of drug flow due to misalignment at the point where the catheter
connects to an implantable pump. As a result, the company has initiated
a voluntary removal of unused products manufactured before the catheter
design change. To reduce the risk for occlusion, Medtronic strongly
recommends that customers discontinue the use of all SC Catheter models
8709SC, 8731SC, 8596SC, 8578 manufactured prior to the design change.
These products are identified by a 'use by' date prior to August
25, 2014. The FDA has classified this notification as a Class I recall.
SynchroMed Implantable Infusion Pump Refill Procedure Safety Update
Medtronic is distributing a revised Clinician Refill Reference Card with
information about the pump refill procedure for the SynchroMed
Implantable Infusion System. This is a continuation of a 2011
notification that was previously classified as a Class I recall. The
revised reference card reflects new product labeling approved by the FDA
to help healthcare professionals reduce the potential for a pocket fill
during the SynchroMed pump refill procedure. A pocket fill is the
inadvertent injection during a refill procedure of all or some of the
prescribed drug into the patient's subcutaneous tissue, which includes
the pump pocket (area under the skin where the pump is placed), instead
of into the pump.
Medtronic continues to focus on improving the quality and reliability of its
implantable drug infusion system. The SynchroMed Implantable Infusion System
continues to demonstrate strong overall reliability, and Medtronic remains
confident in its ability to deliver safe and effective therapy. Patients and
caregivers should be aware of the signs and symptoms associated with intrathecal
drug therapy complications and contact their physicians immediately if they hear
a device alarm or experience symptoms of a drug overdose or underdose. Patients
with questions should contact their physicians.
Additional information is available for healthcare professionals through
Medtronic's website at professional.medtronic.com/iddadvisories
The FDA defines a Class I recall as a situation in which there is a reasonable
probability that the use of, or exposure to, a violative product will cause
serious adverse health consequences or death. Any malfunctions or adverse events
related to a device should be reported to Medtronic Neuromodulation Technical
Services at, 1-800-707-0933, Monday-Friday, 8 a.m. to 5 p.m. CDT, and the FDA's
MedWatch Program at www.fda.gov/MedWatch
Medtronic, Inc. (www.medtronic.com), headquartered in Minneapolis, is the global
leader in medical technology - alleviating pain, restoring health, and extending
life for millions of people around the world.
Any forward-looking statements are subject to risks and uncertainties such as
those described in Medtronic's periodic reports on file with the Securities and
Exchange Commission. Actual results may differ materially from anticipated
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Source: Medtronic, Inc. via Thomson Reuters ONE