BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 2954955 · Received February 11, 2013

    Report

    Report Number
    3007566237-2013-00441
    Event Type
    Malfunction
    Date Received
    February 11, 2013
    Report Date
    January 14, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCT: PRODUCT ID: 8709, SERIAL#: (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ERI OCCURRED ON (B)(6) 2012, AND THE PUMP WAS SCHEDULED FOR REPLACEMENT BY (B)(6) 2013. IT WAS NOTED THAT AN MRI WAS TAKEN OF THE PATIENT'S SPINE AND FOUND THAT HE HAD SEVERAL CYSTS IN HIS SPINAL CORD. THE NEUROSURGEON DID NOT THINK THAT SHE COULD THREAD THE CATHETER UP AT THAT TIME. IT WAS UNCLEAR WHEN THE MRI WAS PERFORMED AND WHEN THE CYSTS WERE DISCOVERED. THE PUMP WAS NOT REPLACED, AND IT WAS NOTED THAT "FOR WHATEVER REASON, THE PATIENT DID NOT SEEK MEDICAL ATTENTION" EVEN THOUGH HE WAS THOUGHT TO HAVE BEEN AWARE THAT THE PUMP WAS GETTING CLOSE TO END OF LIFE. THE PATIENT'S HEALTHCARE PROVIDER (HCP) INDICATED THAT THE PATIENT WAS "PROBABLY IN WITHDRAWAL AND PROBABLY TREMOROUS". IT WAS ALSO REPORTED THAT THE PATIENT HAD SYMPTOMS OF INCREASED SPASMS AND VOMITING. IT WAS ALSO THOUGHT THAT THE PATIENT'S CATHETER MAY HAVE HAD "MICRO-TEARS" AND THAT "SOME OF THE INTRATHECAL BACLOFEN WAS SEEPING IN TO ONE OF THE CYSTS". IT WAS NOTED THAT THE PATIENT'S DOSAGE WAS TITRATED DOWN FROM 1300 MCG/DAY TO 1100 MCG/DAY. THE MEDICATION USED WITHIN THE SYSTEM WAS LIORESAL 2000 MCG/ML. ADDITIONAL INFORMATION WAS REQUESTED BUT NOT AVAILABLE AT THE TIME OF THIS SUBMISSION. A FOLLOW-UP REPORT WILL BE SUBMITTED IF FURTHER INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    59479 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 863740

    Patients

    Seq Age Sex Outcome Treatment
    1