BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ADVANCED

    MDR report key: 2572854 · Received May 14, 2012

    Report

    Report Number
    3004209178-2012-03249
    Event Type
    Malfunction
    Date Received
    May 14, 2012
    Report Date
    April 16, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    EXTENSION: MODEL 7496-51, SERIAL# (B)(4), IMPLANTED: (B)(6) 1992, EXPLANTED: NA. ADAPTOR: MODEL 74001, LOT# N205599, IMPLANTED: (B)(6) 2010, EXPLANTED: NA. LEAD: MODEL 3986A, LOT# N111251, IMPLANTED: (B)(6) 2008, EXPLANTED: NA. RECHARGER: MODEL 37754, SERIAL# (B)(4). PROGRAMMER: MODEL 37744, SERIAL# (B)(4). EXTENSION: MODEL 3708340, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, EXPLANTED: NA. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S STIMULATION TURNED OFF DURING THE NIGHT ONE WEEK AFTER REPLACEMENT. THE PATIENT WAS UNABLE TO ADJUST STIMULATION, AND IT APPEARED THE PROGRAMMER WASN'T WORKING EITHER. HOWEVER, IT WAS VERIFIED THAT THE LIGHTNING BOLT INDICATED THE DEVICE WAS ON. THE DEVICE WAS ON AND WORKING WHEN THE PATIENT CALLED. THERE WAS NO ELECTROMAGNETIC INTERFERENCE NEAR HER BED. THE PATIENT WAS REDIRECTED TO HER PHYSICIAN. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE ADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MDT PUERTO RICO OPERATIONS CO 37713

    Patients

    Seq Age Sex Outcome Treatment
    1