BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSYNC III

    MDR report key: 2910927 · Received January 11, 2013

    Report

    Report Number
    9614453-2013-00018
    Event Type
    Injury
    Date Received
    January 11, 2013
    Date of Event
    December 19, 2012
    Report Date
    February 12, 2013
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    DXY
    PMA / PMN Number
    P010015/S005
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CI
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PROCEDURE TO "CHANGE THE LEAD DUE TO HIGH IMPEDANCE," THE HIGH IMPEDANCE "WAS NOT THE LEAD;" RATHER, THE HIGH IMPEDANCE WAS DUE TO THE "DEVICE BLOCK CONNECTOR." THE DEVICE WAS REMOVED AND REPLACED WITH A NEW DEVICE. NO KNOWN PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    17804 INSYNC III PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE DXY IPG MFG SWITZERLAND 8042U

    Patients

    Seq Age Sex Outcome Treatment
    1 00011 YR Hospitalization| R