BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN SPINAL CORD STIMULATOR

    MDR report key: 2210548 · Received August 10, 2011

    Report

    Report Number
    3007566237-2011-06218
    Event Type
    Injury
    Date Received
    August 10, 2011
    Report Date
    July 15, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A RECHARGEABLE NEUROSTIMULATOR "FOR A SHORT TIME" IN 2008, BUT "COULD NEVER GET IT TO RECHARGE" SO IT WAS REPLACED WITH A NON-RECHARGEABLE UNIT IN 2010. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NO AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN SPINAL CORD STIMULATOR LGW MEDTRONIC NEUROMODULATION IPGNEURO NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention