BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE

    MDR report key: 4752380 · Received May 6, 2015

    Report

    Report Number
    3004209178-2015-08556
    Event Type
    Malfunction
    Date Received
    May 6, 2015
    Report Date
    April 15, 2015
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 377760, LOT# V013515, IMPLANTED: (B)(6) 2006, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD BEEN IN A LOT OF PAIN SINCE (B)(6) 2015. THERE WAS A BURNING PAIN AROUND THE IMPLANT. THE PATIENT WAS HAVING A HARD TIME GETTING UP AND WALKING. 3 DAYS PRIOR, THE PATIENT HAD AN X-RAY BY A PRIMARY CARE PHYSICIAN. A NURSE CALLED BACK YESTERDAY AND SAID THERE WERE POST CHANGES BUT NO SPECIFICS. IT WAS NOTED THAT THE PATIENT COULD SEE THE IMPLANTABLE NEUROSTIMULATOR (INS) THROUGH THE SKIN SINCE 2014. THE PATIENT HAD LOST WEIGHT IN 2014 AND THE NURSE SAID THE CHANGES MIGHT BE DUE TO THE LOSS OF WEIGHT. THE INS WAS VERY CLOSE TO THE SKIN NOW. IT HAD BEEN 9 YEARS SINCE IMPLANT SO EVERYTHING MIGHT BE DRAGGING DOWN. SHE WAS WONDERING IF SHE WOULD GET NAUSEATED AND HAVE PAIN AROUND THE AREA. THE NURSE ALSO SAID SOMETHING ABOUT PINCHED NERVE BUT THEN DIRECTED THE PATIENT TO THE SPINE DOCTOR. IT WAS NOTED THAT THE PATIENT WAS ABLE TO RECHARGE. IT WAS LATER REPORTED THAT IT WAS UNKNOWN IF THERE WAS A 50% OR GREATER SYMPTOM REDUCTION. THERE WAS PAIN IN THE HIP AND REPROGRAMMING WAS PERFORMED BY A MANUFACTURING REPRESENTATIVE (REP). THE CAUSE OF THE EVENT WAS NOT DETERMINED AND THERE WOULD BE A POSSIBLE REPLACEMENT OF THE SPINAL CORD STIMULATOR (SCS). IT WAS NOTED THAT THE PATIENT RECOVERED WITHOUT PERMANENT IMPAIRMENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE SPINAL CORD STIMULATOR (SCS) WAS IMPLANTED 9 YEARS AGO AND IT 'WORKED UNTIL MID-(B)(6) 2015." THERE WAS REPROGRAMMING BY A MANUFACTURING REPRESENTATIVE (REP). THE CAUSE OF THE EVENT WAS NOT DETERMINED AND IT WAS UNKNOWN IF IT WAS DEVICE RELATED. THE PATIENT RECOVERED WITHOUT PERMANENT IMPAIRMENT. THEY CONSIDERED REPLACEMENT OF THE SCS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    297369 RESTORE STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37711

    Patients

    Seq Age Sex Outcome Treatment
    1