BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 2040898 · Received March 23, 2011

    Report

    Report Number
    3007566237-2011-02214
    Event Type
    Malfunction
    Date Received
    March 23, 2011
    Date of Event
    January 13, 2011
    Report Date
    March 14, 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
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - ANALYSIS OF THE PUMP REVEALED BATTERY RESISTANCE HIGH; THE BATTERY RESISTANCE WAVEFORM TEST SHOWED A HIGH RESISTANCE OF 1027 OHMS.

    Description of Event or Problem · 1

    THE RETURN PAPERWORK INDICATED THAT THE PUMP WAS REPLACED PROPHYLACTICALLY TO AVOID IN-VIVO BATTERY DEPLETION BASED ON AN ERI (ELECTIVE REPLACEMENT INDICATOR) OF 3 MONTHS. THERE WAS REPORTED TO BE NO PT INJURY AND THE PT RECOVERED WITHOUT SEQUELA. THE PUMP WAS RETURNED FOR DISPOSAL ONLY. THE DEVICE SYSTEM WAS USED TO DELIVER MORPHINE 15 MG/DL. 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 67 YR IMPLANTED:| EXPLANTED:| CATHETER: MODEL 8731, LOT# N001214035