BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN IMPLANTABLE NUEROSTIMULATOR

    MDR report key: 2841787 · Received November 21, 2012

    Report

    Report Number
    3007566237-2012-02803
    Event Type
    Injury
    Date Received
    November 21, 2012
    Report Date
    October 24, 2012
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    (B)(6): REP STATED PATIENT IS HAVING ISSUES W/ A BUTTOCK IMPLANT AND WILL BE RELOCATED TO THE FLANK. THIS IS EITHER A RESTORE OR RESTORE ADV (LARGER BATTERY) AND IS A FAIRLY SMALLER GENTLEMAN. CALLER REPORTS DUE TO HIPPA, SHE DOES NOT HAVE PT NAME AT THIS POINT. (B)(6) 2012 FROM REP: WE DID A BATTERY SITE REVISION TODAY, MOVED THE BATTERY UP MORE INTO THE FLANK. PATIENT SEEMS TO BE HAPPY WITH RELOCATION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention