BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 2183702 · Received July 8, 2011

    Report

    Report Number
    3007566237-2011-05228
    Event Type
    Malfunction
    Date Received
    July 8, 2011
    Date of Event
    April 13, 2011
    Report Date
    June 16, 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
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): FINAL ANALYSIS OF THE PUMP REPORTED HIGH S2 BATTERY RESISTANCE. THE BATTERY RESISTANCE WAVEFORM TEST SHOWED A HIGH RESISTANCE OF 1440 OHMS.

    Description of Event or Problem · 1

    THE PUMP WAS EXPLANTED DUE TO AN ELECTIVE REPLACEMENT INDICATOR (ERI), NORMAL BATTERY DEPLETION. THERE WERE NO ADVERSE EVENTS AND THE PT RECOVERED WITHOUT SEQUELAE. THE PUMP INFUSED DILAUDID 30 MG/ML, 7.397.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MEDTRONIC NEUROMODULATION 863740 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention CATHETER: MODEL 8703W, LOT# L35692| EXPLANTED:| IMPLANTED: