BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN NEUROSTIMULATOR

    MDR report key: 2881262 · Received December 20, 2012

    Report

    Report Number
    3007566237-2012-03068
    Event Type
    Injury
    Date Received
    December 20, 2012
    Report Date
    November 28, 2012
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A LEAD REVISION APPROXIMATELY ONE YEAR PRIOR TO THE REPORT. ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. SEE MANUFACTURING REPORT #3004209178-2012-12017 FOR RELATED EVENT. THE PATIENT HAD HAD "SHOCKING" SENSATIONS SINCE THE LEAD REVISION.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION INDICATED THAT THE REASON FOR SURGERY ON (B)(6) 2012 WAS THAT THE PATIENT WAS NOT GETTING STIMULATION IN THE RIGHT LEG.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention