BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 2420052 · Received January 18, 2012

    Report

    Report Number
    3004209178-2012-00334
    Event Type
    Injury
    Date Received
    January 18, 2012
    Date of Event
    December 1, 2011
    Report Date
    January 4, 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
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: LEAD MODEL # 3777-75 LOT # V359441005 IMPLANTED (B)(6) 2009 EXPLANTED UNKNOWN; LEAD MODEL # 3777-75 LOT # V289334004 IMPLANTED (B)(6) 2009 EXPLANTED UNKNOWN; ADAPTOR MODEL # 3550-39 LOT # N233062 IMPLANTED (B)(6) 2009 EXPLANTED UNKNOWN; PROGRAMMER MODEL # 37743 LOT # NKE137253N; RECHARGER MODEL # 37752 MODEL # NKA133611N.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA A FACILITY MEDWATCH THAT THE PATIENT, WHO HAD A HISTORY OF CHRONIC NEUROPATHIC PAIN, FELT THE DEVICE DID NOT WORK AND WANTED IT REMOVED. THE PATIENT ALSO EXPERIENCED SHOCKING AFTER THE BATTERY HAD BEEN RECHARGED. IF ADDITIONAL INFORMATION IS RECEIVED, 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 46 YR Required Intervention