BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 2454434 · Received February 16, 2012

    Report

    Report Number
    3004209178-2012-01005
    Event Type
    Malfunction
    Date Received
    February 16, 2012
    Report Date
    January 26, 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

    LEAD MODEL 3587A25, LOT # N240311, IMPLANTED: (B)(6) 2010, EXPLANTED: NA; LEAD MODEL 3587A25, LOT # N165964, IMPLANTED: (B)(6) 2010, EXPLANTED: NA; EXTENSION MODEL 3708360, SERIAL # (B)(4), IMPLANTED: (B)(6) 2010, EXPLANTED: NA; EXTENSION MODEL 3708360, SERIAL # (B)(4), IMPLANTED: (B)(6) 2010, EXPLANTED: NA; PROGRAMMER MODEL 37743, SERIAL # (B)(4); RECHARGER MODEL 37752, SERIAL # (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S STIMULATION HAD BEEN TURNING OFF ON ITS OWN FOR THE PAST TWO WEEKS. THE PATIENT WAS VERIFYING WITH HER PATIENT PROGRAMMER THAT STIMULATION WAS OFF. THE PAST MONTH OF DIARY DATA SHOWED THAT THE PATIENT HAD STIMULATION ON USUALLY 24 HOURS A DAY. RECHARGE STATISTICS SHOWED THAT THE PATIENT WAS RECHARGING WHEN SHE WAS AT 25% OR HIGHER, SO IT DID NOT APPEAR THAT THE LOSS OF STIMULATION SENSATION WAS DUE TO A DISCHARGED NEUROSTIMULATOR. IMPEDANCE MEASUREMENTS WERE NORMAL. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT A MANUFACTURER REPRESENTATIVE MET WITH THE PATIENT TO REPROGRAM THE DEVICE. EVERYTHING, INCLUDING IMPEDANCE, CHECKED OUT OK. THE REPRESENTATIVE LOOKED AT THE PATIENT'S RECHARGING DIARY AND FOUND THAT SHE WASN'T CHARGING CORRECTLY. THE PATIENT WAS EDUCATED ON RECHARGING AND SENT HOME. THE PATIENT WAS DOING GREAT AT THIS POINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE ULTRA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MDT PUERTO RICO OPERATIONS CO 37712

    Patients

    Seq Age Sex Outcome Treatment
    1