BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 2220253 · Received August 16, 2011

    Report

    Report Number
    3004209178-2011-06416
    Event Type
    Injury
    Date Received
    August 16, 2011
    Date of Event
    July 25, 2011
    Report Date
    July 25, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PATIENT WAS STILL HAVING CONCERNS WITH THEIR DEVICE OR THERAPY AND HAD AN APPOINTMENT WITH THEIR HCP ON (B)(6) 2011. A REVISION SURGERY WAS DONE ON (B)(6) 2011 DUE TO PATIENT NOT CHARGING IMPLANTABLE NEUROSTIMULATOR FOR OVER ONE YEAR AND THEREFORE, DEPLETING THE BATTERY. REFER TO MANUFACTURER REPORT # 3004209178-2011-06415.

    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 59 YR Required Intervention EXPLANTED:| LEAD: MODEL 3778, LOT# V100249019| EXPLANTED:| IMPLANTED:| PROGRAMMER: MODEL 37743, LOT# NKE101816N| EXPLANTED:| LEAD: MODEL 3778, LOT# V100249020| EXTENSION: MODEL 37083, LOT# NKC016109N| EXPLANTED:| IMPLANTED:| EXTENSION: MODEL 37081, LOT# NJB032755V| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3986A, LOT# N0039974| EXPLANTED:| IMPLANTED:| LOT# NKF702521H| IMPLANTABLE NEURO STIMULATOR: MODEL 37712| EXPLANTED:| IMPLANTED:| IMPLANTED:| EXPLANTED:| IMPLANTED:| IMPLANTED:| ACCESSORY: MODEL 37752, LOT# NKA111074N