BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOPORE

    MDR report key: 1950906 · Received January 6, 2011

    Report

    Report Number
    2124215-2010-22812
    Event Type
    Injury
    Date Received
    January 6, 2011
    Date of Event
    November 18, 2010
    Report Date
    November 23, 2010
    Manufacturer
    GUIDANT ANGLETON/ST. PAUL
    Product Code
    NVN
    PMA / PMN Number
    K883602
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THERE IS NO FURTHER INFORMATION AVAILABLE AT THIS TIME. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS REPORT WOULD BE UPDATED.

    Additional Manufacturer Narrative · 1

    THE VENTRICULAR LEAD WAS SURGICALLY ABANDONED AND WILL NOT BE RETURNED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS REPORT WOULD BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS DEVICE WAS EXHIBITING VENTRICULAR NOISE WHICH CAUSED OVERSENSING AND PACING INHIBITION FOR 4-5 SECONDS. NOISE COULD NOT BE RECREATED WITH TESTING. IT WAS NOTED THAT THE PATIENT HAD FALLEN DOWN THE WEEK BEFORE AND CUT HER HEAD. A CHEST X-RAY WAS TAKEN AND REVEALED THE RIGHT VENTRICULAR LEAD HAD DISLODGED. IT WAS SUSPECTED THAT THE LEAD DISLODGED WHEN THE PATIENT FELL. A LEAD REVISION WAS SCHEDULED.

    Description of Event or Problem · 1

    FIVE DAYS LATER, IT WAS OBSERVED VIA X-RAY THAT BOTH THE ATRIAL AND VENTRICULAR LEADS HAD FRACTURED. THE LEADS WERE SURGICALLY ABANDONED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOPORE IMPLANTABLE LEAD NVN GUIDANT ANGLETON/ST. PAUL 436-02

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Required Intervention (B)(4)| (B)(4)| 1294| (B)(4)