BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 1943656 · Received December 21, 2010

    Report

    Report Number
    3004209178-2010-10632
    Event Type
    Injury
    Date Received
    December 21, 2010
    Date of Event
    October 7, 2008
    Report Date
    November 5, 2010
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THIS REPORT IS BEING SUBMITTED LATE DUE TO A DELAY BY A MANUFACTURER EMPLOYEE. TRAINING IS IN PLACE.

    Description of Event or Problem · 1

    RECEIVED INFORMATION, THE PATIENT WAS UNABLE TO FULLY RECHARGE THEIR SYSTEM DUE TO POSSIBLE INS INVERSION OR MIGRATION. SURGICAL REVISION WAS DONE AND AN EXTENSION WAS ADDED TO THE SYSTEM. PATIENT RECOVERED WITHOUT SEQUELA.

    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 31 YR Required Intervention EXPLANTED:| EXPLANTED:| IMPLANTED:| IMPLANTED:| LEAD: MODEL 3778, LOT# V117149015| ACCESSORY: MODEL 37752, LOT# NKA116320N| EXTENSION: MODEL 37081, LOT# NJB043400V| PROGRAMMER: MODEL 37743, LOT# NKE105108N