BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 2426684 · Received January 24, 2012

    Report

    Report Number
    3004209178-2012-00465
    Event Type
    Malfunction
    Date Received
    January 24, 2012
    Report Date
    December 27, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    LEAD: MODEL 3887-56, LOT # V120395. LEAD: MODEL 3887-56, LOT # V449129. LEAD: MODEL 3986A60, LOT # N27032. LEAD: MODEL 3986A60, LOT # N27032. EXTENSION: MODEL 37082-40, SERIAL # (B)(4). EXTENSION: MODEL 3708220, 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 "KEPT SHUTTING ITSELF OFF". THE PATIENT EXPERIENCED INTERMITTENT STIMULATION. THE PATIENT WAS REFERRED TO THEIR HEALTH CARE PROVIDER. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT RECEIVED ASSISTANCE FROM HER HCP OR A MANUFACTURER REPRESENTATIVE ON JANUARY 25TH, AND HER CONCERNS WERE RESOLVED.

    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