BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE

    MDR report key: 2991568 · Received March 6, 2013

    Report

    Report Number
    3004209178-2013-03403
    Event Type
    Malfunction
    Date Received
    March 6, 2013
    Date of Event
    February 16, 2013
    Report Date
    February 19, 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
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 3778-75, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: LEAD. PRODUCT ID: 37752, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: RECHARGER. PRODUCT ID: 37742, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: PROGRAMMER. (B)(4).

    Description of Event or Problem · 1

    UPON FURTHER REVIEW, IT WAS REPORTED THAT THE PATIENT WOULD USUALLY CHARGE EVERY TEN DAYS. IT WAS NOTED THAT THE PATIENT FELT A UNCOMFORTABLE FEELING AFTER THE FALL AND ¿LITTLE TUG¿. IT WAS REPORTED THAT THE PATIENT SAW TWO CIRCLES IN THE LEFT HAND CORNER OF THE SCREEN AND A TRIANGLE WITH AN EXCLAMATION POINT. IT WAS NOTED THAT A BEEPING SIGNAL WAS HEARD FROM THE RECHARGER DURING TROUBLE SHOOTING. IT WAS REPORTED THAT THE PATIENT SAW NO BOXES ON THE SCREEN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD COUPLING OR COMMUNICATION ISSUES BETWEEN THE PROGRAMMER AND THE IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS STATED AN INS OVER DISCHARGE WAS SUSPECTED. THE PATIENT TRIED TO USE THE ANTENNA LOCATE (AL) FEATURE, BUT WAS UNABLE TO. AN ERROR MESSAGE APPEARED ON THE PROGRAMMER THAT READ "PR-AV 2.5.00." IT WAS NOTED THAT THE PATIENT HAS NOT HAD MUCH TROUBLE WITH STIMULATION AND STATED THAT "IT'S A WONDERFUL PRODUCT AND SHE LOVED IT." IT WAS REPORTED THAT THE LAST "COUPLE OF TIMES" THE PATIENT HAS HAD DIFFICULTY COMMUNICATING WITH THE INS. THE PATIENT TRIED TO CHARGE BUT WAS UNABLE TO MAKE COMMUNICATION. THE LAST TIME THE PATIENT WAS ABLE TO CHARGE HER INS WAS 10 DAYS PRIOR TO REPORT. THE PATIENT HAS NOT FELT STIMULATION SINCE 3 DAYS PRIOR TO THE REPORT. THE PATIENT WAS EXPERIENCING A LOSS OF THERAPEUTIC EFFECT. IT WAS STATED THAT THE PATIENT'S WEIGHT HAS "FLUCTUATED A LOT." THE PATIENT WAS TAKING PREZONE MEDICATION AND OVER THE YEARS SHE GAINED 45 POUNDS AND THEN LOST WEIGHT. IT WAS STATED THAT THE PATIENT FELT "PUFFY AND FLUID." IT WAS REPORTED THAT THE PATIENT FELL ON (B)(6) 2013. THE PATIENT COULD FEEL A "LITTLE TUG" AROUND THE IMPLANT AREA FOR "ABOUT AN HOUR AFTER THE FALL", AND THEN SHE "FELT FINE." THE PATIENT WAS WORRIED THAT SOMETHING COULD HAVE DISCONNECTED. IT WAS NOTED THAT THE PATIENT HAS BEEN ACTIVE SINCE THE IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    94685 RESTORE STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37711

    Patients

    Seq Age Sex Outcome Treatment
    1 00054 YR