BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN STIMULATOR

    MDR report key: 2881885 · Received December 20, 2012

    Report

    Report Number
    3007566237-2012-03077
    Event Type
    Malfunction
    Date Received
    December 20, 2012
    Date of Event
    November 30, 2012
    Report Date
    November 30, 2012
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3777-75, SERIAL# (B)(4), PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE HEALTH CARE PROVIDER (HCP) WAS UNABLE TO INSERT THE STYLET. IT WAS ALSO NOTED THE STYLET APPEARED TO DO DAMAGE TO THE LEAD AT THE ELECTRODES. THERE WAS NO INJURY, SYMPTOMS OR ADVERSE EVENT TO THE PATIENT. LEAD WAS NOT IMPLANTED. NO FURTHER INFORMATION WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 00025 YR