BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE RECHARGABLE NEUROSTIMULATOR

    MDR report key: 1081288 · Received July 24, 2008

    Report

    Report Number
    3004209178-2008-04313
    Event Type
    Injury
    Date Received
    July 24, 2008
    Date of Event
    September 1, 2007
    Report Date
    June 24, 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
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING A FALL OR OTHER FORM OF TRAUMA THE PT BEGAN EXPERIENCING A SHARP, "STABBING" SENSATION AT THE LEAD INSERTION SITE. THE SHOCKS DID NOT CORRESPOND WITH POSITION CHANGE, THEY WERE "RANDOM". THE PT WAS REPROGRAMMED MULTIPLE TIMES AND HAD X-RAYS TAKEN WHICH SHOWED THE LEAD HAD NOT MIGRATED. THE PT WAS STILL RECEIVING PAIN RELIEF FROM THE SYSTEM AND DID NOT WISH TO HAVE IT REMOVED. IT WAS REPORTED THAT THE SHOCKING WAS WORSE WHEN THE PT WAS RECHARGING. IT WAS ALSO REPORTED THAT THE PT WAS UNABLE TO USE A DIGITAL CAMERA BECAUSE THE DEVICE WOULD SHOOT AUTOMATICALLY. THE PT ALSO REPORTED BEING UNABLE TO TOUCH A GROCERY CART WITHOUT BEING SHOCKED. EXTENSIVE TROUBLESHOOTING OF THE DEVICE DID NOT REVEAL ANY PROBLEMS. IMPEDANCES WERE NORMAL AND ALL OF THE CONNECTIONS CHECKED OUT APPROPRIATELY. AFTER SOME LIGHT PALPATION OF THE THORACOLUMBAR SPINE THE PHYSICIAN WAS ABLE TO REPRODUCE SOME OF THE DISCOMFORT. THE DISCOMFORT SEEMED TO BE IN THE MID PORTION OF THE CICATRIX FROM THE INSERTION SITE ALONG THE THORACOLUMBAR REGION. THE PT UNDERWENT A FLUOROSCOPIC-GUIDED PROCEDURE TO INJECT 2 CC OF 0.25% BUPIVACAINE PLUS 20 MG OF KENALOG ON EACH SIDE OF THE CICATRIX WHERE DISCOMFORT WAS. WHILE PERFORMING THE INJECTION THE PHYSICIAN NOTED A GRATING SENSATION NOTING SCAR TISSUE AT A DEEPER PLANE. THE PT TOLERATED THE PROCEDURE WELL. NO PT OUTCOME WAS REPORTED.

    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 IMPLANTED:| EXTENSION MODEL 37082 LOT# NKB003090N| PROGRAMMER MODEL 37742 LOT# NJD029302N| EXPLANTED:| ACCESSORY MODEL 37752 LOT# NKA021206N| EXPLANTED:| IMPLANTED:| LEAD MODEL 3998 LOT# V010744