BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN SPINAL CORD STIMULATOR

    MDR report key: 1650211 · Received March 31, 2010

    Report

    Report Number
    3007566237-2010-02551
    Event Type
    Injury
    Date Received
    March 31, 2010
    Date of Event
    March 1, 2010
    Report Date
    March 5, 2010
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4): THE DEVICE IS INCLUDED IN THE MEDICAL DEVICE SAFETY ALERT, TITAN ANCHOR FIELD ACTION, PHYSICIAN COMMUNICATION (OCTOBER 27, 2009).

    Description of Event or Problem · 1

    THE PATIENT EXPERIENCED A LOSS OF STIMULATION. UPON REVISION, IT WAS FOUND THAT THE TITAN PART OF THE ANCHOR WAS DISCONNECTED FROM THE SILICON RUBBER. THE PATIENT WAS WITHOUT STIMULATION AND A SURGICAL LEAD IS CONSIDERED PENDING CASE BY CASE APPROVAL.

    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 EXPLANTED:| STIM ACCESSORY: MODEL 3550-39, LOT# 0202693453| EXPLANTED:| LEAD: MODEL 3888, LOT# B0934942K| IMPLANTED:| IMPLANTED: