BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSYNC III

    MDR report key: 1875072 · Received October 19, 2010

    Report

    Report Number
    6000094-2010-02059
    Event Type
    Injury
    Date Received
    October 19, 2010
    Manufacturer
    MEDTRONIC S.A.
    Product Code
    DXY
    PMA / PMN Number
    P010015/S005
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, 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. EVALUATION SUMMARY: (B)(4) NO ANOMALIES FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WAS INTERMITTENT OUTPUT SEEN VIA HOLTER MONITOR, AS WELL AS INTERMITTENT HIGH IMPEDANCE, > 3000 OHMS. AT THE TIME OF LEAD REVISION, WHEN INSERTING A WRENCH INTO THE ATRIAL LEAD IN DEVICE HEADER, THERE WERE AIR BUBBLES AND FLUID NOTED BEING RELEASED AT THE GROMMET. THE LEAD WAS TESTED THROUGH AN ANALYZER, WITH GOOD SENSING AND CAPTURE. THE LEAD WAS LEFT IN USE AND THE PACEMAKER WAS REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSYNC III IMPLANTABLE PULSE GENERATOR DXY MEDTRONIC S.A. 8042 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention 5071 IMPLANTABLE PACING LEAD| 5076-52 IMPLANTABLE PACING LEAD