BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ADVANCED RECHARGEABLE

    MDR report key: 1885194 · Received October 25, 2010

    Report

    Report Number
    3004209178-2010-08422
    Event Type
    Injury
    Date Received
    October 25, 2010
    Date of Event
    September 27, 2010
    Report Date
    September 28, 2010
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A F/U REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Description of Event or Problem · 1

    DURING AN IMPLANT PROCEDURE, A 5-6-5 LEAD WAS FOUND TO BE VERY DIFFICULT TO POSITION MIDLINE. AN X-RAY REVEALED THAT THE LEAD WAS SITTING VERY LATERAL AND ONLY THE OUTERMOST RIGHT CONTACTS WERE MIDLINE. THE DEVICE WAS PROGRAMMED POST-OPERATIVELY THE FOLLOWING DAY. MOST OF THE PATIENT'S STIMULATION WAS FOUND TO BE IN THEIR LEGS, WHEN THE CAUDAL ELECTRODES WERE USED. RIB STIMULATION WAS NOTED, WHEN USING THE CEPHALAD CONTACTS. A PHYSICIAN INITIALLY RECOMMENDED THAT THE PATIENT WAIT WITH RESPECT TO HEALING, AND THEN SEE IF THE STIMULATION CHANGED PRIOR TO UNDERGOING A LEAD REPLACEMENT. LATER, THE PATIENT HAD A LEAD REPLACEMENT ON (B)(6) 2010, IN WHICH A SPECIFY 2X8 LEAD WAS IMPLANTED. THE PATIENT HAD RECOVERED WITHOUT SEQUELA FROM THE SURGICAL PROCEDURE. THE PT'S DEVICE WAS PROGRAMMED ON (B)(6) 2010. THE PT RECEIVED STIMULATION IN HIS LEGS QUITE STRONGLY, BUT ALSO IN HIS LOWER BACK OF WHICH HE HAD NOT FELT BEFORE WITH THE PREVIOUS 5-6-5 LEAD. FOLLOWING THE REPROGRAMMING SESSION THE PATIENT RETURNED, AND STATED THEIR STIMULATION DEVICE HAD "GONE CRAZY". THE STIMULATION WAS NOTED AS HAVING BEEN VERY STRONG. THE DEVICE WAS INTERROGATED, AND IMPEDANCE MEASUREMENTS WERE FOUND TO BE IN WITHIN NORMAL RANGE. THE PATIENT WAS RE-EDUCATED ON POSTOPERATIVE POSITIONAL CHANGES, AND WAS INSTRUCTED TO ADJUST THE STIMULATOR TO HIS COMFORT. A F/U VISIT WAS RESCHEDULED FOR 2 WEEKS LATER. ADD'L INFO WILL BE PROVIDED IN A F/U REPORT AS IT BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE ADVANCED RECHARGEABLE LGW MDT PUERTO RICO OPERATIONS CO., JUNCOS 37713 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention IMPLANTED:| EXPLANTED:| ACCESSORY: MODEL 37752, LOT# NKA141354N| STIM ACCESSORY: MODEL 3550-39, LOT# N257029| EXPLANTED:| IMPLANTED:| EXPLANTED:| IMPLANTED:| EXPLANTED:| LEAD: MODEL 39286-65, LOT# V509733045| EXPLANTED:| LEAD: MODEL 39565-65, LOT# V439886017| IMPLANTED:| IMPLANTED:| PROGRAMMER: MODEL 37743, LOT #NKE149594N