BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE

    MDR report key: 3299643 · Received August 21, 2013

    Report

    Report Number
    3004209178-2013-14903
    Event Type
    Malfunction
    Date Received
    August 21, 2013
    Report Date
    July 26, 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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 37742, SERIAL# (B)(4), IMPLANTED: 2006 (B)(6); PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 377760, LOT# V004735, IMPLANTED: 2006 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 377760, LOT# V003346, IMPLANTED: 2006 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 377760, LOT# V004735, IMPLANTED: 2006 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 377760, LOT# V003346, IMPLANTED: 2006 (B)(6); PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AT THE TIME OF IMPLANT, THE PATIENT FELT THE LEADS "WEREN'T GROUND OUT REALLY GOOD." IT WAS STATED THAT "STIM WAS TURNED UP PRETTY HIGH (7.5), THE LADY WHO PROGRAMMED THE PATIENT THOUGHT IT WAS HIGH AND SAID HE SHOULD BE GETTING SHOCKED." THE PATIENT WASN'T FEELING STRONG STIMULATION, UNTIL HE WENT INTO THE PARKING LOT AND BENT OVER, AND THE STIMULATION "JOLTED HIM" AND "HE BECAME PARALYZED" BY THE STIMULATION. THE STIMULATION WAS THEN LOWERED AND THE PATIENT WAS OK AND COULD MOVE AGAIN. IT WAS STATED THAT "AFTER FOR THE PAST FEW YEARS, THE PATIENT NOTICED HE WOULD HAVE TO JUMP BECAUSE, IT WOULD GROUND OUT MORE THAN OTHER TIMES AND WHEN LAYING DOWN." ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. WHEN RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    404913 RESTORE STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37711

    Patients

    Seq Age Sex Outcome Treatment
    1 00066 YR