BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANTABLE NEURO STIMULATOR

    MDR report key: 7624683 · Received June 21, 2018

    Report

    Report Number
    3007566237-2018-01847
    Event Type
    Injury
    Date Received
    June 21, 2018
    Date of Event
    November 19, 2012
    Report Date
    July 17, 2018
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: NEU_UNKNOWN_LEAD, PRODUCT TYPE: LEAD. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    CORRECTION TO EVENT DATE. EVENT DATE SHOULD BE UNKNOWN. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM WAS RECEIVED FROM A CONSUMER REGARDING ANOTHER PATIENT WITH AN IMPLANTABLE NEURO STIMULATOR (INS). PATIENT SAID REGARDING THE OTHER ONES WITH "LITTLE WIRES" (PATIENT POSSIBLY MEANT OTHER MEDTRONIC DEVICES) EVERYTHING THAT HE READ ABOUT THEM SAID "OH I BENT OVER AND I HAD TO HAVE THE WIRE ATTACHED OR REPLACED", "OH I DID THIS AND THIS HAPPENED OR THAT HAPPENED". PATIENT SAID HE WAS REFERRING TO MANUFACTURE MADE EQUIPMENT, PATIENT SAID THAT THERE IS A VIDEO ON THE MANUFACTURERS WEBSITE. PATIENT SAID THE GUY THAT SAID THE COMMENT ABOUT "BENDING OVER AND HAVING TO HAVE HIS LEAD REATTACHED OR REPLACED" DID NOT PROVIDE NAME JUST USED INITIALS. PATIENT SAID PEOPLE ON THE SITE "JUST WANT TO KNOW INFORMATION WAS RECEIVED FROM LIKE WHY IS MY LEG DOING THIS OR THAT TYPE OF THING" NO PATIENT SYMPTOMS OR COMPLICATIONS WERE REPORTED IN THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    466797 IMPLANTABLE NEURO STIMULATOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention