BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ADVANCED RECHARGEABLE

    MDR report key: 2070148 · Received April 21, 2011

    Report

    Report Number
    3004209178-2011-02989
    Event Type
    Injury
    Date Received
    April 21, 2011
    Date of Event
    January 1, 2010
    Report Date
    March 31, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PT'S DEVICE WAS REMOVED DUE TO WOUND DEHISCENCE. THE BATTERY, LEAD AND EXTENSION WERE ALL REMOVED. THE PT RECOVERED WITHOUT SEQUELA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE ADVANCED RECHARGEABLE LGW MDT PUERTO RICO OPERATIONS CO., JUNCOS 37713 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention LEAD: MODEL 3898, LOT# LB2182| IMPLANTED:| EXPLANTED:| IMPLANTED:| EXPLANTED:| EXTENSION: MODEL 7471, LOT# NHJ003485N