BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 3892431 · Received June 24, 2014

    Report

    Report Number
    3007566237-2014-01760
    Event Type
    Injury
    Date Received
    June 24, 2014
    Report Date
    June 4, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE ANALYSIS: ANALYSIS OF THE LEAD FOUND THAT ¿ALL EIGHT CONDUCTORS WERE BROKEN 24.8 CM FROM THE DISTAL END OF THE LEAD AT THE DISTAL EDGE OF THE TITAN ANCHOR LOCATION.¿

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3878, LOT# UNKNOWN, IMPLANTED: (B)(6) 2011, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ANALYSIS IS COMPLETE.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION REPORTED THAT AS OF 22 DAYS AFTER INITIAL REPORT, THE PATIENT WAS RECEIVING EFFECTIVE PARESTHESIA IN THE APPROPRIATE AREA. IT WAS STATED THE PATIENT ¿FELT PAIN RELIEF AGAIN¿ WITH HER NEW LEAD WHILE HER STIMULATOR WAS TURNED ON. IT WAS NOTED THE PATIENT WAS ¿DOING WELL.¿

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT¿S LEAD HAD AN IMPEDANCE MEASUREMENT OF ¿>40000¿ OHMS ON THE NUMBER 8 ELECTRODE. IT WAS STATED THE ¿FIBROSIS SURROUNDING THE ELECTRODE WAS HEAVY¿ AT THE TIME OF EXPLANT. IT WAS FURTHER STATED THE OPERATING PHYSICIAN SAW THE ¿PART OF THE ELECTRODE [WHERE] HE CONSIDERED THE PROBLEM WAS¿ AND ¿HE DECIDED TO CUT¿ THAT PORTION OUT AND PARTIALLY EXPLANT THE LEAD. IT WAS NOTED A NEW LEAD WAS SUCCESSFULLY IMPLANTED AT THE TIME OF THE PROCEDURE. IT WAS REPORTED THERE WERE ¿NO¿ PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THE EVENT AND THE PATIENT WAS ALIVE WITH NO INJURY AT THE TIME OF REPORT. IT WAS NOTED THE PATIENT¿S STIMULATION WAS LEFT OFF UNTIL THE IMPEDANCE ISSUE WAS RESOLVED. ADDITIONAL INFORMATION HAS BEEN REQUESTED; A SUPPLEMENTAL REPORT WILL BE FILED IF ADDITIONAL INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    367634 UNKNOWN IMPLANTABLE NEUROSTIMULATOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 00053 YR Required Intervention