BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 2172351 · Received June 23, 2011

    Report

    Report Number
    3007566237-2011-04745
    Event Type
    Malfunction
    Date Received
    June 23, 2011
    Date of Event
    July 7, 2010
    Report Date
    May 27, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE PRIMARY FINDING WAS BATTERY RESISTANCE HIGH. THE BATTERY RESISTANCE WAVEFORM TEST SHOWED A HIGH RESISTANCE OF 1081 OHMS. THE BATTERY LOGS OF THE BCT FILE SHOWED .62 VOLT DROP DURING THE BATTERY RESISTANCE COMMAND TEST.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SYSTEM WAS REPLACED ON (B)(6) 2010 FOR NORMAL DEPLETION. THE REPORTER VAGUELY RECALLED THAT BACLOFEN WAS USED IN THE SYSTEM, AND THOUGHT THAT IT WAS LIKELY A PROPHYLACTIC REPLACEMENT IN ANTICIPATION OF BATTERY EOS. NO EVENTS WERE REPORTED AS LEADING UP TO THE REPLACEMENT OR SINCE THE REPLACEMENT. SURGERY WAS ROUTINE AND RECOVERY WAS WITHOUT SEQUELAE. ON (B)(6) 2011 PRODUCT WAS RETURNED "FOR DISPOSAL ONLY".

    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 40 YR CATHETER: MODEL 8709, LOT# J12044R29| EXPLANTED:| IMPLANTED: