BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE

    MDR report key: 3932533 · Received July 14, 2014

    Report

    Report Number
    3004209178-2014-12974
    Event Type
    Malfunction
    Date Received
    July 14, 2014
    Report Date
    June 23, 2014
    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
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3708260, SERIAL # (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE EXTENSION; PRODUCT ID 3998, LOT # V034832, IMPLANTED: (B)(6) 2007, PRODUCT TYPE LEAD; PRODUCT ID 37742, SERIAL # (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE PATIENT RECEIVED ASSISTANCE FROM THEIR DOCTOR OR A MANUFACTURER REPRESENTATIVE AND THEIR CONCERNS WERE RESOLVED. THE PATIENT DID NOT HAVE ANY CONCERNS WITH THEIR DEVICE OR THERAPY AT THE TIME OF THE REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT NOTICED THAT THEIR STIMULATOR ¿WASN¿T WORKING¿ A DAY PRIOR TO THE REPORT. THE DEVICE HAD TURNED OFF. THE PATIENT CHECKED THEIR IMPLANTABLE NEUROSTIMULATOR (INS) WITH THEIR PROGRAMMER AND IT HAD NO CHARGE IN THE INS. THE PATIENT CHARGED RELIGIOUSLY EVERY SUNDAY. THE PATIENT CHARGED THE SUNDAY PRIOR TO THE REPORT FROM 1 PM UNTIL 10 PM. IT TOOK 3-4 HOURS TO CHARGE TO HALF FULL SO THE PATIENT CHARGED AGAIN ON THE MORNING OF THE REPORT. THE PATIENT THOUGHT THAT THEIR INS WENT FROM FULL TO EMPTY IN THE COURSE OF ONE EVENING. THE PATIENT HAD GOTTEN ALL 8 COUPLING BOXES FILLED IN THE LAST FEW TIMES THEY HAD CHARGED. THE PATIENT¿S INS TENDED TO SHUT OFF ¿FOR NO REASON¿. THIS ISSUE STARTED 6 MONTHS PRIOR TO THE REPORT. THE PATIENT WAS NOT SURE IF ANY ERROR CODES HAD EVER SHOWN UP WHEN THEY CHECKED THEIR INS WITH THEIR PROGRAMMER. THE PATIENT HAD NOT HAD ANY FALLS OR TRAUMA PRIOR TO THE INS SHUTTING OFF ISSUES. IT WAS FURTHER REPORTED THAT THE PATIENT¿S STIMULATION COULD TURN ON FOR NO REASON. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    409602 RESTORE STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37711

    Patients

    Seq Age Sex Outcome Treatment
    1