BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 2841558 · Received November 21, 2012

    Report

    Report Number
    3007566237-2012-02801
    Event Type
    Injury
    Date Received
    November 21, 2012
    Report Date
    October 24, 2012
    Manufacturer
    MEDTRONIC NEUROMODULATION (SULLIVAN LAKE)
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID NEU_UNKNOWN_LEAD, PRODUCT TYPE LEAD, (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD HAD ONE LEAD BREAK PRIOR TO 2000, AND THAT HE HAD A REVISION AND UPDATED LEADS WERE IMPLANTED. THE PATIENT STATED THAT HIS LEADS ARE DOING "JUST FINE" IN TERMS OF PLACEMENT. THE PATIENT REPORTED THAT HIS CURRENT DEVICE WAS WORKING FINE. NO FURTHER INFORMATION AS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN IMPLANTABLE NEUROSTIMULATOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC NEUROMODULATION (SULLIVAN LAKE) NEU_INS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention