BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 2434768 · Received February 1, 2012

    Report

    Report Number
    3007566237-2012-00215
    Event Type
    Injury
    Date Received
    February 1, 2012
    Report Date
    January 11, 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 37081, LOT # UNK, SERIAL # UNKNOWN, IMPLANTED: UNK EXPLANTED: UNK.

    Additional Manufacturer Narrative · 1

    EXTENSION MODEL # 3708140 LOT # NJB103973V IMPLANTED 2011-(B)(6) EXPLANTED UNKNOWN; PROGRAMMER MODEL # 37743 LOT # NKE171512N; LEAD MODEL # 3888-45 LOT # V780541 IMPLANTED 2011-(B)(6) EXPLANTED 2012-(B)(6); LEAD MODEL # 3888-45 LOT # V780541 IMPLANTED 2011-(B)(6) EXPLANTED 2012-(B)(6); RECHARGER MODEL # 37752 LOT # NKA156706N; EXTENSION MODEL # 3708240 LOT # NKB004720V IMPLANTED 2011-(B)(6) EXPLANTED UNKNOWN; LEAD MODEL # 3777-45 LOT # V879946016 IMPLANTED 2011-(B)(6) EXPLANTED 2012-(B)(6). ADDITIONAL INFORMATION DETERMINED THAT THE CORRECT MANUFACTURING SITE FOR THIS EVENT IS SITE # 3004209178.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN INFECTION. THE LOCATION OF THE PATIENT'S SYMPTOMS WAS AT THE LEAD LOCATION. THE LEAD WAS REMOVED AND THE PATIENT WAS CURRENTLY RECOVERED FROM THE INFECTION. LEAD REPLACEMENT SURGERY WAS PLANNED FOR THE NEAR FUTURE. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED NOTED THAT THE PATIENT EXPERIENCED SKIN BREAKDOWN. A REVISION OCCURRED. REGARDING HOW THE PATIENT WAS NOW AND IF THEY WERE RECEIVING EFFECTIVE THERAPY IT WAS NOTED "YES".

    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 Required Intervention