BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 2160915 · Received June 16, 2011

    Report

    Report Number
    3007566237-2011-04517
    Event Type
    Malfunction
    Date Received
    June 16, 2011
    Report Date
    May 23, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Removal / Correction Number
    Z-2276-2009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): FINAL ANALYSIS OF THE PUMP REPORTED HIGH S2 BATTERY RESISTANCE. LOGS SHOWED MULTIPLE LOW BATTERY RESETS, SAFE STATE.

    Description of Event or Problem · 1

    A DEVICE REMOVAL AND PROPHYLACTIC REPLACEMENT WAS REPORTED DUE TO ELECTIVE REPLACEMENT ELECTIVE INDICATOR (ERI). THE REASON WAS REPORTED AS BATTERY DEPLETION. NO PT SYMPTOMS WERE REPORTED PRIOR THE REPLACEMENT. THE PT RECOVERED WITHOUT SEQUELAE; NO INJURY. THE DRUG INFUSED THROUGH THE PUMP WAS BACLOFEN (LIORESAL) 350.5 MG/DAY, CONCENTRATION: 2000 MCG/ML. THE DEVICE WAS RETURNED FOR ANALYSIS AND DISPOSAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MEDTRONIC NEUROMODULATION 863740 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR EXPLANTED:| IMPLANTED:| CATHETER: MODEL 8711, LOT# J11948R15