BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ADVANCED

    MDR report key: 3182998 · Received June 21, 2013

    Report

    Report Number
    3004209178-2013-10731
    Event Type
    Injury
    Date Received
    June 21, 2013
    Report Date
    May 28, 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

    CONCOMITANT PRODUCTS: PRODUCT ID 3550-29, PRODUCT TYPE ACCESSORY; PRODUCT ID 37752, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE RECHARGER; PRODUCT ID 3777-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE LEAD; PRODUCT ID 37742, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Additional Manufacturer Narrative · 1

    ANALYSIS OF NEUROSTIMULATOR MODEL 37713 SERIAL # (B)(4) SHOWED NO SIGNIFICANT ANOMALIES AND THE DEVICE WAS FOUND TO BE AT END-OF-SERVICE (EOS) DUE TO 3 OVERDISCHARGE CONDITIONS. THE DEVICE WAS RECOVERED FOLLOWING (B)(4) PHYSICIAN MODE RECHARGE (PMR) PROCEDURES (NOTED THAT (B)(4) OVERDISCHARGE EVENTS WERE ALSO SEEN). THE REASON FOR THE MULTIPLE PMRS WAS THAT THE DEVICE WOULD RAPIDLY CHARGE THEN RAPIDLY DISCHARGE. GOOD STABLE OUTPUT WAS SEEN FOLLOWING THE PMR RECOVERY AND NO RECHARGE ISSUES WERE OBSERVED. ANALYSIS OF PLUG/BOOT, MODEL 3550-29, ACCESSORY SHOWED NO ANOMALIES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT¿S PAIN LEVEL WAS TOLERABLE SO SHE STOPPED USING THE IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS NOTED THAT THE INS WAS OVERDISCHARGED. IT WAS FURTHER NOTED THAT THE DEVICE WAS EXPLANTED. IT WAS NOTED THAT IT WASNOT NORMAL BATTERY DEPLETION. IT WAS FURTHER NOTED THAT THE PATIENT RECOVERED WITHOUT SEQUELA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282520 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 Required Intervention