BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANTABLE SPINAL CORD STIMULATOR

    MDR report key: 3883570 · Received June 19, 2014

    Report

    Report Number
    3007566237-2014-01716
    Event Type
    Injury
    Date Received
    June 19, 2014
    Date of Event
    November 1, 2013
    Report Date
    October 2, 2018
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID: NEU_UNKNOWN_LEAD, SERIAL# UNKNOWN, PRODUCT TYPE: LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    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

    IT WAS REPORTED THE PATIENT WAS IMPLANTED IN (B)(6) 2013 AND THE DEVICE ¿WORK GREAT FOR ABOUT A MONTH¿. IT WAS REPORTED THAT AROUND (B)(6) OF 2013 THE DEVICE SENT A ¿VERY INTENSE SHOCK¿ THROUGH THE PATIENT¿S BODY WHILE THEY WERE JUST SITTING AND RELAXING. IT WAS NOTED THAT SINCE THEN THE DEVICE HAS NOT WORKED PROPERLY AND FOR THE ¿LAST THREE MONTHS¿ PRIOR TO THE REPORT HAS BASICALLY NOT WORKED AT ALL. IT WAS REPORTED THE PATIENT CAN SET THE AMPS TO A MAX OF 10.5 AND NOT FEEL ANYTHING IN EITHER LEAD. IT WAS NOTED THAT WHEN THE DEVICE WAS WORKING THEY HAD TO CHARGE THEIR DEVICE EVERY THREE DAYS AND NOW THE CHARGE THE DEVICE EVERY EIGHT DAYS. IT WAS REPORTED THAT THE IMPLANTED BATTERY GETS VERY ¿EXTREMELY HOT¿ WHEN IT IS BEING RECHARGED. IT WAS NOTED THAT THE PATIENT¿S HEALTH CARE PROVIDER (HCP) ¿KEEPS POSTPONING THE REPLACEMENT OF THE NEW BATTERY FOR SEVERAL MONTHS¿.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS IMPLANTED ON (B)(6) 2013 AND ONE MONTH AFTER IMPLANT THE PATIENT STARTED TO GET "SEVER SHOCKS" THROUGHOUT THEIR BODY. IT WAS NOTED 8.5 MONTHS AFTER IMPLANT THE SYSTEM WAS COMPLETELY REPLACED. IT WAS REPORTED THE PATIENT BELIEVED THE "LEADS WERE BURNT BETWEEN THE SPINE AND BATTERY". IT WAS NOTED THE PATIENT WAS SCHEDULED FOR ONLY A BATTERY REPLACEMENT HOWEVER THE ENTIRE SYSTEM WAS REPLACED IT WAS FOUND THE LEADS WERE THE PROBLEM. THIS INFORMATION WAS PREVIOUSLY REPORTED IN MANUFACTURING REPORT # 3007566237-2014-02072 PRIOR TO BEING MERGED INTO THIS EVENT. ANY FURTHER INFORMATION RECEIVED WILL BE UPDATED ACCORDINGLY IN THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    359956 IMPLANTABLE SPINAL CORD STIMULATOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1