BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE

    MDR report key: 2463067 · Received February 21, 2012

    Report

    Report Number
    3004209178-2012-01122
    Event Type
    Malfunction
    Date Received
    February 21, 2012
    Report Date
    January 25, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    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

    PROGRAMMER: MODEL 37743, SERIAL# (B)(4). RECHARGER: MODEL 37752, SERIAL# (B)(4). LEAD: MODEL 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, EXPLANTED: NA. LEAD ACCESSORY: MODEL 3550-29, LOT# N213163, IMPLANTED: (B)(6) 2010, EXPLANTED: NA.

    Description of Event or Problem · 1

    THE PATIENT EXPERIENCED A SHOCKING SENSATION IN HIS NORMAL PARESTHESIA COVERAGE AREA EVEN THOUGH THE INS WAS TURNED DOWN TO 0V. THE INS WAS STILL TECHNICALLY ON WHEN IT WAS INTERROGATED. A FEW OF THE CONTACT IMPEDANCE MEASUREMENTS WERE GREATER THAN 3,600 OHMS. HIS INS WAS REPROGRAMMED. ALL OF THE OPEN CIRCUIT CONTACTS WERE PROGRAMMED OFF AND THE PATIENT FELT GOOD COVERAGE/STIMULATION.

    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