BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 4120833 · Received September 26, 2014

    Report

    Report Number
    3007566237-2014-02707
    Event Type
    Injury
    Date Received
    September 26, 2014
    Report Date
    September 4, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: NEU_PTM_PROG, SERIAL# UNKNOWN, PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: NEU_UNKNOWN_LEAD, SERIAL# UNKNOWN, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT INFORMATION WAS REQUESTED REGARDING LONGEVITY OF A SPINAL CORD STIMULATOR (SCS) AND THE COMPONENTS OF ITS¿ SYSTEM. IT WAS NOTED THAT A CONSUMER OF AN SCS DEVICE HAD IT FOR 15 YEARS BUT HAD A MAJOR FALL AND THE WOMAN NEEDS TO HAVE THE IMPLANTABLE NEUROSTIMULATOR (INS) AND LEADS REPLACED. IT WAS NOTED THIS PATIENT WAS IN OUTPATIENT AND WAS THERE FOR JUST A DAY. IT WAS UNKNOWN WHAT THE WOMAN¿S NAME WAS. NO FURTHER INFORMATION WAS ABLE TO BE OBTAINED AS THE WOMAN REPORTING THIS EVENT COULD NOT REMEMBER THE PATIENT¿S NAME AND HAD NO FURTHER INFORMATION REGARDING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    601881 UNKNOWN IMPLANTABLE NEUROSTIMULATOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention