BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ADVANCED RECHARGEABLE

    MDR report key: 1213286 · Received October 27, 2008

    Report

    Report Number
    3004209178-2008-06899
    Event Type
    Injury
    Date Received
    October 27, 2008
    Date of Event
    August 15, 2008
    Report Date
    September 26, 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
    KY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT EXPERIENCED SEVERE STOMACH PAIN IMMEDIATELY FOLLOWING IMPLANT OF THE NEUROSTIMULATION DEVICE IN 2008. THE PATIENT WAS IN RECOVERY FOR THE IMPLANT, AND WAS CRYING, REPORTING THE SEVERE STOMACH PAIN. MORPHINE DID NOT NUMB THE PAIN. WHEN THE PATIENT REMAINED STILL, THE PAIN WENT AWAY, BUT AS SOON AS THE PATIENT MOVED THE PAIN RETURNED ACROSS THE LOWER STOMACH. THE PATIENT REMAINED IN PAIN FOR THREE WEEKS WHILE UNDERGOING TESTING. X-RAYS, CAT SCANS, AND URINE TESTS WERE PERFORMED. THE PATIENT FELT THE STIMULATOR WAS TOUCHING A NERVE OR MUSCLE. AT ABOUT THREE WEEKS LATER, THE STIMULATION DEVICE WAS REMOVED. THE PATIENT REPORTED IMMEDIATE RELIEF FROM THE PAIN. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention ACCESSORY: MODEL 37752| EXPLANTED:| EXTENSION:MODEL 37081| EXTENSION: MODEL 37081| EXPLANTED:| LEAD: MODEL 39565| EXPLANTED:| PROGRAMMER: MODEL 37743