BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 1852166 · Received September 29, 2010

    Report

    Report Number
    3007566237-2010-07435
    Event Type
    Malfunction
    Date Received
    September 29, 2010
    Report Date
    September 1, 2010
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT COULD NOT WALK, FELT VERY WEAK, AND OVERMEDICATED. THE ONSET OF THE PT'S SYMPTOMS WAS NOTED AS OCCURRING AFTER THE PT HAD BEEN "ELECTROCUTED". THE PT'S OUTCOME WAS NOT REPORTED. ADDITIONAL INFO HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MEDTRONIC NEUROMODULATION 8637 NA

    Patients

    Seq Age Sex Outcome Treatment
    1