BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 2461564 · Received February 20, 2012

    Report

    Report Number
    3004209178-2012-01082
    Event Type
    Malfunction
    Date Received
    February 20, 2012
    Report Date
    January 24, 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 3587A25, LOT # N230423. LEAD: MODEL 3587A25, LOT # N136907. EXTENSION: MODEL 37082-60, SERIAL # (B)(4). PROGRAMMER: MODEL 37743, SERIAL # (B)(4). RECHARGER: MODEL 37752, SERIAL # (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT'S DEVICE WAS TURNING OFF INTERMITTENTLY. THE DEVICE WAS INTERROGATED AND NO PROBLEMS COULD BE FOUND. THE PATIENT PLANNED TO KEEP A LOG OF THE EVENTS AND WOULD CONTACT THE MANUFACTURER OR THEIR HEALTHCARE PROVIDER IF THE PROBLEM PERSISTED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SENT.

    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