BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 2093025 · Received May 3, 2011

    Report

    Report Number
    3004209178-2011-03218
    Event Type
    Malfunction
    Date Received
    May 3, 2011
    Date of Event
    May 1, 2010
    Report Date
    April 18, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, FOLLOWING IMPLANT, THE PATIENT RETURNED FOR REPROGRAMMING ON (B)(6) 2010. THE HCP WAS UNABLE TO PROVIDE COVERAGE OF THE PATIENT'S REGIONS OF CHRONIC PAIN. REFERENCE MFR. REPORT # 3004209178201004357 FOR INFORMATION REGARDING PATIENT'S PREVIOUS DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE ULTRA LGW MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS 37712 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR PROGRAMMER: MODEL 37743, LOT# NKE127406N| IMPLANTED:| IMPLANTED:| LOT# NKF710999H| IMPLANTABLE NEURO STIMULATOR: MODEL 37712,| IMPLANTED:| LEAD: MODEL 39286-30, LOT# V419081004| IMPLANTED:| EXTENSION: MODEL 37081, LOT# NJB070203V| IMPLANTED:| EXTENSION: MODEL 37081, LOT# NJB073477V| ACCESSORY: MODEL 37752, LOT# NKA127209N| LEAD: MODEL 3778, LOT# V255098037| EXPLANTED:| LEAD: MODEL 3778, LOT# V250466010| EXPLANTED:| IMPLANTED:| EXPLANTED:| EXPLANTED:| IMPLANTED:| EXPLANTED:| EXPLANTED:| EXPLANTED:| EXPLANTED:| IMPLANTED: