BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 2061792 · Received March 30, 2011

    Report

    Report Number
    3007566237-2011-02406
    Event Type
    Malfunction
    Date Received
    March 30, 2011
    Date of Event
    April 19, 2010
    Report Date
    March 21, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - ANALYSIS OF THE PUMP REVEALED S2 BATTERY RESISTANCE HIGH; THE BATTERY RESISTANCE WAVEFORM TEST SHOWED A HIGH RESISTANCE OF 1326 OHMS.

    Description of Event or Problem · 1

    THE PUMP WAS REPLACED. THE RETURN PAPERWORK INDICATED "NORMAL BATTERY DEPLETION". THERE WAS REPORTED TO BE NO PATIENT INJURY AND THE PATIENT RECOVERED WITHOUT SEQUELA. THE DEVICE SYSTEM WAS USED TO DELIVER BACLOFEN 2000 MCG/ML. THE PUMP UNDERWENT ROUTINE ANALYSIS UPON RECEIPT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MEDTRONIC NEUROMODULATION 863720 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR IMPLANTED:| EXPLANTED:| CATHETER: MODEL 8575, LOT# J12272R| EXPLANTED:| CATHETER: MODEL 8709, LOT# L78417| IMPLANTED: