BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNERGY

    MDR report key: 2140941 · Received June 21, 2011

    Report

    Report Number
    3004209178-2011-04629
    Event Type
    Injury
    Date Received
    June 21, 2011
    Date of Event
    May 18, 2011
    Report Date
    May 18, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD THE DEVICE EXPLANTED DUE TO PAIN. THE DEVICE WAS REPLACED AND THERE WERE NO INJURIES NOTED DURING THE EXPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNERGY LGW MDT PUERTO RICO OPERATIONS CO., JUNCOS 7427V NA

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention IMPLANTED:| LEAD: MODEL 3487A, LOT# J0012680V| EXPLANTED:| IMPLANTED:| UNKNOWN CONVERSION TYPE: MODEL 3550-09,LOT# L83784| EXTENSION: MODEL 7495-66, LOT# XS0005751N| EXPLANTED:| IMPLANTED:| EXPLANTED:| PROGRAMMER: MODEL 7435, LOT# NFT007472P