BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 3765294 · Received April 22, 2014

    Report

    Report Number
    3007566237-2014-01090
    Event Type
    Injury
    Date Received
    April 22, 2014
    Report Date
    May 15, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 355531, LOT # N440965, PRODUCT TYPE SCREENING; DEVICE PRODUCT ID 355531, LOT # N422014, PRODUCT TYPE SCREENING DEVICE; PRODUCT ID NEU_UNKNOWN_LEAD, SERIAL # UNKNOWN, PRODUCT TYPE LEAD; PRODUCT ID NEU_UNKNOWN_LEAD, SERIAL # UNKNOWN, PRODUCT TYPE LEAD. (B)(4). ANALYSIS OF THE MULTI-LEAD TRAILING CABLE (LOT # N440965) FOUND THAT THE STIMULATION SCREENING CABLE'S DISTAL END CONNECTOR HAD FOREIGN MATERIAL.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT IS DOING WELL. IT WAS REPORTED THERE WERE NO PROBLEMS WITH THE LEADS BUT THAT THEY HAD MOVED AND NEEDED REPLACING. IT WAS REPORTED THE TESTING WAS DONE TO INSURE THAT EVERYTHING WAS FINE WITH THE NEW LEAD. IT WAS NOTED THAT ONCE THE MULTI-LEAD TRIALING CABLE (MLTC) WAS SWITCHED ¿EVERYTHING WAS GOOD GO¿.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE MULTI-LEAD TRIALING CABLE (MLTC) WAS FAULTY. IT WAS ALSO NOTED THAT THERE WAS A KNOWN ISSUE WITH 1 LEAD WHERE THEY WERE GETTING IMPEDANCES OF ¿???¿ AND THE LEAD WAS REPLACED FOR THAT REASON. WHEN THE REPLACEMENT LEAD WAS TESTED WITH THE MLTC THE IMPEDANCES SHOWED GREATER THAN 10,000. WHEN A DIFFERENT MLTC WAS TRIED THE READINGS WERE BACK TO EXPECTED. THE MLTC WAS RETURNED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    242370 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