BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 2000321 · Received February 18, 2011

    Report

    Report Number
    3004209178-2011-01242
    Event Type
    Injury
    Date Received
    February 18, 2011
    Date of Event
    October 1, 2010
    Report Date
    January 31, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PT HAD LEAD REVISION IN (B)(6) 2010 AND HAS NOT CHARGED THEIR DEVICE SINCE. THE PT EXPERIENCED COUPLING/COMMUNICATION AND TELEMETRY ISSUES. THE DEVICE WAS OVERDISCHARGED AND A POWER ON RESET (POR) OCCURRED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Required Intervention IMPLANTED:| EXPLANTED:| PROGRAMMER: MODEL 37743, LOT# NKE135100N| LEAD: MODEL 3778, LOT# V327866015| EXPLANTED:| ACCESSORY: MODEL 37752, LOT# NKA132370N| LEAD: MODEL 3778, LOT# V327866014| IMPLANTED: