BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNERGY

    MDR report key: 2690596 · Received August 10, 2012

    Report

    Report Number
    3004209178-2012-06746
    Event Type
    Malfunction
    Date Received
    August 10, 2012
    Report Date
    July 11, 2012
    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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 748951, SERIAL# (B)(4), IMPLANTED: (B)(6) 2005, PRODUCT TYPE: EXTENSION. PRODUCT ID: 748951, SERIAL# (B)(4), IMPLANTED: (B)(6) 2005, PRODUCT TYPE: EXTENSION. PRODUCT ID: 7435,SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER. PATIENT PRODUCT ID: 3587A, LOT# N0039776, IMPLANTED: (B)(6)2005, PRODUCT TYPE LEAD PRODUCT ID 3587A LOT# N0038951 SERIAL# IMPLANTED: 2005-09-08 EXPLANTED: PRODUCT TYPE :LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S IMPLANTABLE NEUROSTIMULATOR (INS) DISPLAYED A "POWER ON RESET" (POR) CONDITION ABOUT 18 MONTHS AGO. DURING THE POR, THE PATIENT BELIEVED SHE WAS NOT GETTING THE SAME THERAPEUTIC BENEFIT AS BEFORE. THE PATIENT WAS REPROGRAMMED IN NOVEMBER, BUT NOTICED THE CHANGE IN THERAPY IN DECEMBER AND ALSO NOTICED THE PATIENT PROGRAMMER BATTERY STATUS LIGHT FLASHED. THERE WERE NO ELECTROMAGNETIC INTERFERENCE EVENTS ASSOCIATED WITH THE POR. IT WAS ALSO NOTED THAT SINCE THE POR, THE PHYSICIAN STATED THAT "THINGS GOT ALL TURNED AROUND" AND HE REPROGRAMMED THE SYSTEM IN (B)(6). IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNERGY STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7427

    Patients

    Seq Age Sex Outcome Treatment
    1