BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE SENSOR

    MDR report key: 3003847 · Received March 14, 2013

    Report

    Report Number
    3004209178-2013-03694
    Event Type
    Injury
    Date Received
    March 14, 2013
    Report Date
    February 22, 2013
    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
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID 39565-65, SERIAL # (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE LEAD; PRODUCT ID 37754, SERIAL # (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 37746, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER. (B)(4).

    Description of Event or Problem · 1

    FOLLOW UP INFORMATION REPORTED THAT THE PATIENT INDEED HAD THE REVISION SURGERY. THE PATIENT WAS SEEN POSTOPERATIVELY AND WAS REPORTED AS DOING WELL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT LOST COVERAGE IN HIS BACK AND DOWN HIS LEGS ON ABOUT (B)(6) 2013. THE PATIENT HAD LESS THAN FIFTY PERCENT THERAPY RELIEF. THE PATIENT BEGAN FEELING STIMULATION IN HIS ABDOMEN, SO WAS REPROGRAMMED ON (B)(6) 2013. THE PATIENT GOT BACK SOME LEG COVERAGE AT THE BOTTOM OF THE LEAD, EVEN THOUGH THE PATIENT'S PREVIOUS PROGRAMMING WAS AT THE TOP OF THE LEAD AND COVERED HIS BACK AND BOTH LEGS. THE LEAD PREDOMINATELY GOT ABDOMINAL AND RIB STIMULATION AND THE IMPEDANCES WERE WITHIN NORMAL LIMITS. AN X-RAY TAKEN APPEARED TO SHOW THAT THE LEAD HAD MOVED UP SINCE IMPLANT AND THE HEALTH CARE PROVIDER (HCP) PLANNED FOR A LEAD REVISION. ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    107484 RESTORE SENSOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37714

    Patients

    Seq Age Sex Outcome Treatment
    1 00038 YR Required Intervention