BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 2043607 · Received March 28, 2011

    Report

    Report Number
    3007566237-2011-02330
    Event Type
    Malfunction
    Date Received
    March 28, 2011
    Date of Event
    January 25, 2011
    Report Date
    March 10, 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
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): BATTERY FAILED THE BATTERY RESISTANCE WAVEFORM TEST WITH HIGH RESISTANCE OF 1257 OHMS. ALL LOGS AND TELEMETRY STRIPS WERE REVIEWED AND NO LOW BATTERY RESET, ERI, OR SAFE STATE EVENTS WERE FOUND TO HAVE OCCURRED. THE PRIMARY FINDING WAS S2 BATTERY RESISTANCE HIGH.

    Description of Event or Problem · 1

    THE PUMP DISPLAYED THE EARLY REPLACEMENT INDICATOR OF 10 MONTHS. IT WAS REMOVED PROPHYLACTICALLY. THERE WAS NO PT INJURY ASSOCIATED WITH THE EVENT. THE PT RECOVERED W/O SEQUELA AFTER REPLACEMENT. THE PUMP WAS USED TO DELIVER MORPHINE.

    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 54 YR CATHETER: MODEL 8709, LOT# J12173R12| EXPLANTED:| IMPLANTED: