BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 2320449 · Received November 2, 2011

    Report

    Report Number
    3007566237-2011-08961
    Event Type
    Malfunction
    Date Received
    November 2, 2011
    Date of Event
    July 8, 2011
    Report Date
    October 13, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Removal / Correction Number
    Z# 3043-2011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ANALYSIS OF THE DEVICE WAS RE-VISITED TO REFLECT THAT CAUSE OF THE RESET-LOW BATTERY FAILURE IN THE LAB. IT WAS CONCLUDED THAT THERE WAS PUMP MOTOR CORROSION AND FEEDTHRU ANOMALY. THE PUMP DID REACH ERI (ELECTIVE REPLACEMENT INDICATOR) FOR TIME ELAPSED WHICH IS A NORMAL OPERATION. THE PUMP BATTERY PASSED TESTING. THE H6 EVALUATION CODES REMAIN THE SAME/UNCHANGED.

    Additional Manufacturer Narrative · 1

    FINAL ANALYSIS OF THE RETURNED DEVICE CONCLUDED A S2 LOW BATTERY RESET (LBR) THAT OCCURRED DURING THE BATTERY COMMAND TEST (BCT). LBR WAS BELIEVED "TO HAVE CAUSED BY A TEMPORARY SHORT ACROSS THE MOOR WIRE FEEDTHRUS". M1 FEEDTHRU SHOWED SIGNS OF RESIDUE AND DARK RESIDUE SURROUNDING MOTOR WIRES FEEDTHRUS WERE OBSERVED. THERE WAS EVIDENCE OF RESIDUE IN M1 INSULATING GLASS. ANALYSIS FURTHER NOTED THAT ERI (ELECTIVE REPLACEMENT INDICATOR) OCCURRED IN THE FIELD WHILE THE LBR OCCURRED IN THE LAB DURING THE BCT. DRUG DELIVERED VIA THE DEVICE PER ANALYSIS WAS SUFENTA. (B)(4).

    Description of Event or Problem · 1

    THE DEVICE WAS RECEIVED AND ANALYSIS WAS PERFORMED. NO INFORMATION WAS PROVIDED WITH THE DEVICE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 00055 YR