BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 2211909 · Received August 10, 2011

    Report

    Report Number
    3007566237-2011-06227
    Event Type
    Malfunction
    Date Received
    August 10, 2011
    Date of Event
    August 3, 2010
    Report Date
    July 20, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). FINAL ANALYSIS OF THE PUMP REVEALED S2 BATTERY RESISTANCE HIGH: BATTERY ELECTRICAL RESISTANCE EXCEEDS SPECIFICATION.

    Description of Event or Problem · 1

    NO EVENT WAS REPORTED. THE PUMP WAS REPLACED FOR "BATTERY DEPLETION". PT RECOVERED WITHOUT SEQUELAE. THE DRUGS INFUSED WERE DILAUDID AND BACLOFEN.

    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 50 YR