BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ADVANCED RECHARGABLE

    MDR report key: 1130904 · Received August 21, 2008

    Report

    Report Number
    3004209178-2008-05116
    Event Type
    Injury
    Date Received
    August 21, 2008
    Date of Event
    June 23, 2008
    Report Date
    July 21, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THE DEVICE WAS REPLACED WITH RESTORE ULTRA. THE REASON FOR REPLACEMENT WAS NOT PROVIDED. IT WAS DISCLOSED THAT A DOG JUMPED ON THE PT'S CHEST. THE PT FELT SOMETHING PULL. IT WAS UNCLEAR WHETHER THE DOG JUMPED ON THE PT'S CHEST WHILE THE DEVICE WAS IMPLANTED OR AFTER THE REPLACEMENT. ADD'L INFO HAS BEEN REQUESTED FROM THE HCP, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE ADVANCED RECHARGABLE LGW MEDTRONIC PUERTO RICO OPERATIONS CO 37713 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention EXPLANTED| IMPLANTED| LEAD MODEL 3986A LOT # N073729| LEAD MODEL 3986A LOT# N073729| IMPLANTED| EXTENSION MODEL 37082 LOT# NKB002748N| EXPLANTED| EXPLANTED| IMPLANTED