BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ADVANCED

    MDR report key: 2972737 · Received February 21, 2013

    Report

    Report Number
    3004209178-2013-02958
    Event Type
    Injury
    Date Received
    February 21, 2013
    Report Date
    September 6, 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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 399945, LOT# V176130, IMPLANTED: (B)(6) 2009, PRODUCT TYPE: LEAD. PRODUCT ID: 3777-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: LEAD. PRODUCT ID: 37743, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER. PATIENT PRODUCT ID: 3708260, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN IMPLANTABLE NEUROSTIMULATOR (INS) WAS CHARGING MORE THAN EXPECTED. THE PATIENT WAS CHARGING DAILY FOR 1-2 HOURS BUT IT WAS STATED THAT IT USED TO CHARGE ONCE A WEEK. THERE WAS A QUESTIONABLE HISTORY OF OVERDISCHARGE (OD), NO OD HAD BEEN PREVIOUSLY REPORTED. ESTIMATED RECHARGE INTERVAL WAS CALCULATED ON LONGEVITY CALCULATOR BASED ON 2 PROGRAMS: 6.1V, 450 MICROSECONDS, 50HZ, 262 OHMS; 4.2V, 450 MICROSECONDS, 426 OHMS. THE CALCULATION SHOWED 8 DAYS BEGINNING OF LIFE (BOL) TO 4 DAYS END OF LIFE (EOL) FOR THE BATTERY TO LAST FROM FULL TO DISCHARGED. IT WAS ALSO REPORTED THAT WHILE STIMULATION WAS TURNED ON, A LOSS OF THERAPEUTIC EFFECT OCCURRED. IT WAS STATED THAT THE PATIENT KEPT "TOP HALF OF INS (50-100%) CHARGED" AS SHE NOTICED THAT HER PAIN WAS "OUT OF CONTROL" WHEN HER INS WAS 50% CHARGED AND HER STIMULATION CHANGED AT THAT POINT. THIS WAS SOMETHING THAT HAD STARTED TO OCCUR RECENTLY. THE INS WAS REPROGRAMMED RECENTLY AS WELL AND PARAMETERS MIGHT HAVE CHANGED. THE RECHARGE STATISTICS OBTAINED WERE: (B)(6) 2013, 1.9HR S, 75%; (B)(6) 2013, 1.1HRS, 75%; (B)(6) 2013, 0.1HRS 50%; (B)(6) 2013, 0.5 HRS, 50%; (B)(6) 2013, 2.4HRS, 100%; (B)(6) 2013, 1.6HRS, 100%. ELECTRODE IMPEDANCES WERE GENERALLY BETWEEN 1800-2800 OHMS. FOUR DAYS LATER IT WAS REPORTED THAT THERE WERE NO ELECTRODE IMPEDANCE OR GROUP IMPEDANCE ISSUES. NO X-RAYS WERE TAKEN. BATTERY REPLACEMENT WAS DISCUSSED, A SURGERY WAS TO BE PLANNED, THE DATE WAS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    76753 RESTORE ADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37713

    Patients

    Seq Age Sex Outcome Treatment
    1 00066 YR Required Intervention