BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE PRIME

    MDR report key: 2220008 · Received August 9, 2011

    Report

    Report Number
    3004209178-2011-06186
    Event Type
    Malfunction
    Date Received
    August 9, 2011
    Date of Event
    July 1, 2011
    Report Date
    July 14, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT WAS NOT ABLE TO ADJUST THE STIMULATION. A "CALL YOUR DOCTOR" ICON WAS DISPLAYED ON THE PT'S PROGRAMMER. AN OUT OF RANGE (OOR) CONDITION WAS ENCOUNTERED. THERE WERE ALSO LOW, OUT OF RANGE, IMPEDANCE READINGS OF LESS THAN 70 OHMS ON ELECTRODES 4 - 12, 5 - 13, AND 6 - 14. THE PT'S SETTINGS WERE 3+, 4+ WITH 10-, 11-, 12+, 13+. THE PT WAS THEN REPROGRAMMED TO: 2+, 3+, 10-, 11-, 12+, 13+. BUT, THE IMPEDANCE READING WAS THEN FOUND TO BE 78 OHMS. THE ELECTRODE IMPEDANCE FOR 3 - 11 WAS 238. THE PT WAS SUBSEQUENTLY REPROGRAMMED TO: 3+, 10-, 12+ WITH A GROUP IMPEDANCE READING OF 413 OHMS. THE STIMULATION HELPED WITH THE PT'S PAIN RELIEF AT THIS SETTING. IT WAS LATER REPORTED THAT AFTER TROUBLESHOOTING, A SHORT CIRCUIT WAS FOUND AT ELECTRODES 3 AND 11; 4 AND 12; AND 5 AND 13. THE MFR REP REPROGRAMMED THE DEVICE USING OTHER ELECTRODES. STIMULATION WAS ACHIEVED THAT THE PT DESIRED. THE PT WAS SATISFIED WITH THE REPROGRAMMING. THE PHYSICIAN WAS TO PERFORM FLUOROSCOPY AT THE NEXT PT VISIT IN ORDER TO DETERMINE IF THE LEADS HAD MOVED. A F/U REPORT WILL BE FILED IF ADD'L INFO BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE PRIME LGW MDT PUERTO RICO OPERATIONS CO., JUNCOS 37701 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR PROGRAMMER: MODEL 37743, LOT# NKE159423N| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3776, LOT# V498804029| LEAD: MODEL 3776, LOT# V589801012| IMPLANTED:| EXPLANTED: