BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE PRIME

    MDR report key: 3133686 · Received May 29, 2013

    Report

    Report Number
    3004209178-2013-08237
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Report Date
    May 9, 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
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 37746, SERIAL# (B)(4). PRODUCT TYPE: PROGRAMMER, PATIENT: PRODUCT ID 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012. PRODUCT TYPE: LEAD: PRODUCT ID 37746, SERIAL# (B)(4). PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD NO STIMULATION SENSATION AND WHEN THE PATIENT RAISED THEIR ARMS THEY DID NOT FEEL ANYTHING. IT WAS STATED THE PATIENT DID NOT FEEL STIMULATION WHEN THEIR ARMS WERE LOWERED EITHER. IT WAS NOTED THE PATIENT STATED THIS CHANGE OCCURRED THE DAY PRIOR TO REPORT AND THERE WERE NO KNOWN ACCIDENTS OR INCIDENTS RELATED TO THE COMPLAINT. IT WAS ALSO REPORTED THE SCREEN WAS BLANK ON THE PATIENT¿S PROGRAMMER. IT WAS LATER REPORTED THE PATIENT WAS STILL NOT FEELING STIMULATION IN THEIR BACK AFTER CHANGING THE BATTERIES IN THEIR PROGRAMMER. IT WAS ALSO STATED THE PATIENT HAD NOT FELT STIMULATION SINCE THREE DAYS PRIOR TO REPORT. IT WAS STATED THE PATIENT ASKED IF THEY SHOULD BE FEELING A SHOCK WHEN THEY RAISED THEIR ARM. IT WAS ALSO NOTED THE PATIENT STILL DID NOT FEEL STIMULATION AFTER INCREASING THE STIMULATION TO 2.45 VOLTS. IT WAS REPORTED THE PATIENT HAD NO FALLS OR TRAUMA BUT DID HAVE A LOSS OF THERAPEUTIC EFFECT. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION REPORTED THAT THE PATIENT'S IMPLANT QUIT WORKING, IT WAS REPORTED THAT "THE MACHINE IT SHOWS THAT IT'S WORKING" BUT PATIENT WAS NOT FEELING STIMULATION. IT WAS REPORTED THAT AFTER TROUBLESHOOTING WITH PATIENT PROGRAMMER, IT WAS WORKING BUT PATIENT WAS "NOT REALLY" FEELING STIMULATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236083 RESTORE PRIME STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37701

    Patients

    Seq Age Sex Outcome Treatment
    1 00061 YR