BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ADVANCED

    MDR report key: 4542638 · Received February 24, 2015

    Report

    Report Number
    3007566237-2015-00451
    Event Type
    Injury
    Date Received
    February 24, 2015
    Date of Event
    February 5, 2015
    Report Date
    February 5, 2015
    Manufacturer
    MEDTRONIC NEUROMODULATION
    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

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT: PRODUCT ID 3708360, SERIAL# (B)(4), IMPLANTED: 2006-(B)(6), PRODUCT TYPE EXTENSION. PRODUCT ID 3998, LOT# V001940, IMPLANTED: 2006-(B)(6), PRODUCT TYPE LEAD. PRODUCT ID 37742, SERIAL# (B)(4), IMPLANTED: 2006-(B)(6), PRODUCT TYPE PROGRAMMER, PATIENT. PRODUCT ID 37752, SERIAL# (B)(4), IMPLANTED: 2006-(B)(6), PRODUCT TYPE RECHARGER. PRODUCT ID 3708360, SERIAL# (B)(4), IMPLANTED: 2006-(B)(6), PRODUCT TYPE EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WERE READING >40,000 OHMS. WITH 0 REFERENCE THE ELECTRODE PAIR GAVE VALUES: 08 31000; 09 31000; 011 31000; 01, 02, AND 010 >40000. WITH REFERENCE 3 -8 9, AND 11 WERE WITHIN RANGE AND 03, 13, 23, AND 310 WERE OUT OF RANGE. WITH 8 AS REFERENCE AT 0.7VOLTS: 03 1285 OHMS, 09 1042 OHMS, 011 1109 OHMS, AND ALL OTHER PAIRS >10000. WITH 3 AND 11, THE PATIENT FELT NOT STIMULATION UP TO 10.5 VOLTS. WITH 8 AND 11, THE PATIENT FELT STIMULATION IN THE RIGHT LEG AND HE WAS GETTING GOOD COVERAGE WITH HIS PAIR AS THE REP INCREASED VOLTAGE. WITH PAIR 0 AND 3, THE PATIENT DID NOT FEEL STIMULATION UP TO 10.5 VOLTS. IN THE OPERATING ROOM (OR), IMPEDANCES ON 0-3 WERE OKAY, BUT THE REP DID NOT HAVE VALUES FOR THE OTHERS. IT WAS LATER REPORTED THAT THE CAUSE OF THE EVENT WAS NOT DETERMINED, BUT THERE WAS SPECULATION THAT THERE WAS A LEAD FRACTURE. THE PATIENT HAD HIGHER THAN NORMAL IMPEDANCES PRIOR TO THE DEVICE REPLACEMENT SURGERY. PRIOR DEVICE IMPEDANCES WERE CHECKED BEFORE REPLACEMENT, AND WERE FOUND TO BE HIGHER THAN NORMAL. UPON IMPEDANCES CHECK POST-OP, IMPEDANCES WERE OVER 40,000 ON SEVERAL ELECTRODES. THEY TROUBLESHOOTED PROGRAMMING OPTIONS AND THE PATIENT DID RECEIVED STIMULATION IN THE RIGHT LEG BUT NEEDED IT IN THE LEG AS WELL, BUT WERE UNABLE TO ACHIEVE STIMULATION. THE IMPLANTING PHYSICIAN DISCUSSED THAT THE LEAD MAY HAVE BEEN DAMAGED PREVIOUSLY AND NOW WOULD REQUIRE REVISION TO ACHIEVE ADEQUATE STIMULATION. THE PATIENT AGREED, AND IT WAS SCHEDULED FOR 2015-(B)(6). THE LEAD AND EXTENSION WERE REPLACED AND THE INTRA-OP IMPEDANCES WERE WITHIN NORMAL RANGE. THE PATIENT WAS IN POST-OP AND THE REP WAS GOING TO PROGRAM IN THE MORNING. THE PATIENT WAS PROGRAMMED POSTOPERATIVELY WITHOUT DIFFICULTY, AND THE PATIENT HAD EXCELLENT PAIN RELIEF. NO PRODUCT WAS GOING TO BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    130680 RESTORE ADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC NEUROMODULATION 37713

    Patients

    Seq Age Sex Outcome Treatment
    1 00055 YR Required Intervention