BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 1890193 · Received October 22, 2010

    Report

    Report Number
    3004209178-2010-08282
    Event Type
    Malfunction
    Date Received
    October 22, 2010
    Date of Event
    June 1, 2010
    Report Date
    June 27, 2010
    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
    AZ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). REASON FOR LATE MDR DUE TO IMPLEMENTATION OF PROCESS IMPROVEMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PT EXPERIENCED A SHOCKING OR JOLTING SENSATION. IT WAS STATED THAT THE PT'S DEVICE WAS REPROGRAMMED, AND THE PROBLEM WAS CORRECTED. THERAPY WAS RESTORED AND THE PT 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 68 YR IMPLANTED:| EXPLANTED:| EXPLANTED:| ACCESSORY: MODEL 37752, LOT # NKA129256N| IMPLANTED:| LEAD: MODEL 3890, LOT # J0348999V| IMPLANTED:| EXPLANTED:| EXTENSION: MODEL 7489, LOT # NHU034101V| IMPLANTED:| PROGRAMMER: MODEL 37743, LOT # NKE128416N| EXPLANTED: