BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE PRIME ADVANCED

    MDR report key: 1213287 · Received October 27, 2008

    Report

    Report Number
    3004209178-2008-06890
    Event Type
    Injury
    Date Received
    October 27, 2008
    Date of Event
    July 16, 2008
    Report Date
    September 26, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT EXPERIENCED PAIN AT THE LEAD SITE, DUE TO A MIGRATION OR DISLODGEMENT. THE LEAD WAS EXPLANTED AND REPLACED. THE PATIENT RECOVERED WITHOUT SEQUELA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE PRIME ADVANCED LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 37702 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention PROGRAMMER: MODEL 37743| EXTENSION: MODEL 37081| EXPLANTED:| LEAD: MODEL 3778| EXPLANTED: