SynchroMed Implantable Infusion System Recall [US]


US FDA RecallUS/Silver Spring: FDA LogoMedtronic issues four medical device notifications concerning its SynchroMed Implantable Infusion System due to operational failure hazards. FDA: http://ht.ly/mvnrH

Direct link: http://www.fda.gov/Safety/Recalls/ucm359069.htm

Additional information:
The US Food and Drug Administration (“FDA”) reports Medtronic’s intrathecal drug delivery systems are used to treat chronic, intractable pain and severe spasticity of cerebral or spinal origin.

According to the FDA, Medtronic issued four notifications to provide doctors and other heath care providers with information to help identify and manage safety issues concerning the SynchroMed Implantable Infusion System. The FDA has classified three of these four notifications as new Class I recalls. The fourth notification is an update to a 2011 action related to pump refill that was previously classified by the FDA as a Class I recall.

The four recalls concern the following:

  • SynchroMed Implantable Infusion Pump Priming Bolus: 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.
  • SynchroMed Implantable Infusion Pump Shorting: 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.
  • 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.
  • 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. You can download the card here: http://professional.medtronic.com/pt/neuro/idd/ind/product-advisories/index.htm?cmpid=URL_Neuro_HCP_iddadvisories_-

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