BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ADVANCED RECHARGEABLE

    MDR report key: 1111555 · Received August 13, 2008

    Report

    Report Number
    3004209178-2008-04907
    Event Type
    Injury
    Date Received
    August 13, 2008
    Date of Event
    June 26, 2008
    Report Date
    July 16, 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
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PULSE GENERATOR MIGRATED TO A SUPERFICIAL AND CAUDAL POSITION. THE PT HAD PAIN AT THE PULSE GENERATOR SITE. THE PT HAD A SURGICAL INTERVENTION. THE HCP REPORTED THE PT OUTCOME AS 'RECOVERED WITHOUT SEQUELA'.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention EXTENSION MODEL 37082| EXTENSION MODEL 37082| EXPLANTED| EXPLANTED| PROGRAMMER MODEL 37742| LEAD MODEL 3487A| EXPLANTED| LEAD MODEL 3487A| EXPLANTED| EXPLANTED| LEAD MODEL 3487A| EXPLANTED| LEAD MODEL 3487A