BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE SENSOR

    MDR report key: 2951358 · Received February 9, 2013

    Report

    Report Number
    3004209178-2013-01509
    Event Type
    Malfunction
    Date Received
    February 9, 2013
    Report Date
    January 21, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ANALYSIS OF THE IMPLANTABLE NEUROSTIMULATOR (INS) REVEALED SERVE LIFE STARTED PREMATURELY. THE INS WAS RECEIVED IN AN OVERDISCHARGED STATE WHILE STILL IN THE UNOPENED SHRINK WRAPPED BOX. ACCORDING TO THE TRACE REPORT TAKEN FROM THE INS, THE SERVICE LIFE WAS STARTED ON (B)(6) 2012, AND THE INS WAS RECHARGED TO FULL FROM 3.815 VOLTS. THIS WAS APPROXIMATELY 6 MONTHS AFTER THE MANUFACTURE DATE SO IT APPEARS THAT THE DRAIN WHILE IN THE SHIPPING MODE WAS NORMAL. AFTER THE IMPLANT LIFE WAS STARTED, IT IS NO LONGER IN THE SHIPPING MODE AND THE INS WILL DRAIN FASTER. THIS INS DEPLETED TO THE "LOCK" MODE ON (B)(6) 2012, AND WOULD SUBSEQUENTLY DEPLETE TO AN OVERDISCHARGED STATE APPROXIMATELY 30 DAYS LATER. THE INS WAS NOT RECHARGED AGAIN UNTIL IT WAS RECEIVED IN THE ANALYSIS LAB. THE INS PASSED FUNCTIONAL TESTING.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION REPORTED THAT THE IMPLANTABLE NEUROSTIMULATOR (INS) THAT HAD PROBLEMS KEEPING A CHARGE WAS NEVER IMPLANTED IN THE PATIENT. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WERE "PROBLEMS" WITH THE DEVICE KEEPING A CHARGE. NO FURTHER INFORMATION WAS REPORTED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    57193 RESTORE SENSOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MDT PUERTO RICO OPERATIONS CO 37714

    Patients

    Seq Age Sex Outcome Treatment
    1