BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE RECHARGABLE NEUROSTIMULATOR

    MDR report key: 1133147 · Received August 22, 2008

    Report

    Report Number
    3004209178-2008-05179
    Event Type
    Malfunction
    Date Received
    August 22, 2008
    Date of Event
    December 1, 2007
    Report Date
    July 25, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THE STIMULATION WAS IN THE WRONG LOCATION, FOLLOWING AN UNRELATED MEDICAL PROCEDURE, LUMBAR FUSION, ROD REMOVAL/REPLACEMENT. POST LUMBAR SURGERY, THE DEVICE SYSTEM QUIT WORKING. THE PATIENT EXPERIENCED A SHOCKING OR JOLTING SENSATION AND LACK OF EFFECT. AT THE TIME OF THE REPORT THE PATIENT WAS AT HOME IN GOOD CONDITION. IT WAS REPORTED A LEAD BROKE OFF, AND WAS TORN INSIDE THE PATIENT'S BODY. THE PATIENT HAD A CT SCAN TO VERIFY THE LEAD WAS IN THE SPINAL CANAL. THE HCP REVIEWED FILMS PRE-OPERATIVELY AND POST-OPERATIVELY. MRI CLEARLY REVEALED ONE LEAD PULLED BACK CAUDAL AND DORSAL, MOST LIKELY WITH NECESSARY TISSUE RETRACTION WITH L5 SURGERY. THE HCP STATED IT DID NOT LOOK LIKE A DEVICE DEFECT OR MALFUNCTION. ONE OR BOTH LEADS PULLED. EXPLANTATION OR REVISION SURGERY WAS PROBABLE. A DECISION WAS NEEDED ABOUT REIMPLANTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE RECHARGABLE NEUROSTIMULATOR LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 37711 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention EXPLANTED:| LEAD: MODEL 3777| IMPLANTED:| EXTENSION: MODEL 37081| IMPLANTED:| IMPLANTED:| EXPLANTED:| EXPLANTED:| EXPLANTED:| EXTENSION: MODEL 37081| LEAD: MODEL 3777| IMPLANTED: