BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE

    MDR report key: 2475461 · Received March 2, 2012

    Report

    Report Number
    3004209178-2012-01315
    Event Type
    Malfunction
    Date Received
    March 2, 2012
    Report Date
    February 6, 2012
    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

    LEAD MODEL 399930 LOT V011456 IMPLANTED: (B)(6) 2006 EXPLANTED: UNK. EXTENSION MODEL 3708340 (B)(4) IMPLANTED: (B)(6) 2006 EXPLANTED: UNK. EXTENSION MODEL 3708340 (B)(4) IMPLANTED: (B)(6) 2006 EXPLANTED: UNK. PROGRAMMER MODEL 37742 (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD TELEMETRY ISSUES AND A SUSPECTED OVERDISCHARGE. THE PATIENT HAD BEEN CHARGING ALMOST DAILY, AND WAS NOT SATISFIED WITH THE CHARGING FREQUENCY. THE PATIENT HAS A HISTORY OF 1 OR 2 PRIOR OVERDISCHARGES. FOR THIS MOST RECENT OVERDISCHARGE, MULTIPLE PHYSICIAN MODE RESETS HAD BEEN COMPLETED BUT WERE UNSUCCESSFUL IN REGAINING TELEMETRY. THE PATIENT PLANNED TO HAVE THE DEVICE REPLACED. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MDT PUERTO RICO OPERATIONS CO 37711

    Patients

    Seq Age Sex Outcome Treatment
    1