BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSYNC III

    MDR report key: 2864841 · Received December 10, 2012

    Report

    Report Number
    3002807576-2012-00001
    Event Type
    Injury
    Date Received
    December 10, 2012
    Report Date
    October 16, 2012
    Manufacturer
    MEDTRONIC S.A.
    Product Code
    LWP
    PMA / PMN Number
    P010015/S005
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER THE PATIENT LOST WEIGHT, THE PATIENT COMPLAINED OF SEVERE ABDOMINAL DISCOMFORT AND PAIN WHEN BENDING OVER. THE DEVICE WAS ELECTIVELY EXPLANTED AND REPLACED. THE PATIENT IS A PARTICIPANT IN THE SYSTEM LONGEVITY STUDY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSYNC III PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MEDTRONIC S.A. 8042

    Patients

    Seq Age Sex Outcome Treatment
    1 00057 YR Hospitalization| R 4968 IMPLANTABLE PACING LEAD