BEUDAMED
    FDA Adverse Event Summary report: N

    SYNCHROMED II

    MDR report key: 2222755 · Received August 11, 2011

    Report

    Report Number
    3007566237-2011-06277
    Date Received
    August 11, 2011
    Date of Event
    March 11, 2011
    Report Date
    July 21, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 1625 OHMS.

    Description of Event or Problem · 1

    NO INFO WAS PROVIDED.

    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 52 YR EXPLANTED:| CATHETER: MODEL 8731, LOT# B010315N32| IMPLANTED: