BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXTEND IS-1 BI POSITIVE FIX

    MDR report key: 1043035 · Received May 8, 2008

    Report

    Report Number
    2124215-2008-33619
    Event Type
    Injury
    Date Received
    May 8, 2008
    Date of Event
    February 18, 2008
    Report Date
    January 7, 2011
    Manufacturer
    CARDIAC PACEMAKERS, INC
    Product Code
    NVN
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE LEAD WAS SUCCESSFULLY REPOSITIONED. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE TO OUR COMPANY, THE EVENT WILL BE REOPENED AND UPDATED AS NECESSARY. TWO YEARS LATER THE LEAD WAS RETURNED AND IS CURRENTLY IN ANALYSIS. WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, THE COMPLETE LEAD WAS RETURNED. DRIED BLOOD WAS VISIBLE PAST THE HELIX MECHANISM AND UP THROUGH THE LEAD LUMEN AND DRIED TISSUE WAS OBSERVED AT THE BASE OF THE HELIX HOUSING. DAMAGE WAS OBSERVED TO THE LEAD'S HELIX, INSULATION AND CONDUCTOR COILS. THE LEAD WAS THEN SUBJECTED TO RESISTANCE AND HIPOT TESTING TO VERIFY THE LEAD'S ELECTRICAL PERFORMANCE AND INNER INSULATION INTEGRITY. MEASUREMENTS THROUGH OUT THESE TESTS WERE WITHIN NORMAL LIMITS. PRESSURE TESTING WAS NOT PERFORMED DUE TO THE DAMAGE NOTED TO THE LEAD'S OUTER INSULATION. THE LEAD DID NOT PASS HELIX TESTING AS IT WOULD NOT RETRACT. THIS WAS MOST LIKELY DUE TO THE DRIED BODY FLUID IN THE MECHANISM. LABORATORY ANALYSIS CONCLUDED THE DAMAGE TO THE LEAD'S INSULATION AND CONDUCTOR COILS WAS LIKELY PROCEDURALLY INDUCED. THE ALLEGATION OF LOSS OF CAPTURE WAS NOT CONFIRMED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC (BSC) CRM RECEIVED INFORMATION THAT THIS BSC SALES REPRESENTATIVE (SR) CALLED TECHNICAL SERVICES (TS) REPORTING THIS PATIENT WAS ADMITTED TO THE EMERGENCY ROOM TWO DAYS POST THEIR IMPLANT PROCEDURE. THE PATIENT HAD SYMPTOMS OF SHORTNESS OF BREATH, LETHARGIC AND SYNCOPE. IT WAS SPECULATED THAT A POSSIBLE LEAD PERFORATION OCCURRED, HOWEVER THERE WAS NO CONFIRMATION OF THIS. AN ECHOGRAM WAS THEN PERFORMED WHICH REVEALED THE PATIENT HAD PNEUMOTHORAX. TWO LITERS OF FLUID WERE REMOVED FROM THE PATIENT'S CHEST TUBE AND THE PATIENT HAD DOCUMENTED LOSS OF RIGHT VENTRICULAR CAPTURE. A CAT SCAN WAS PERFORMED WHICH REVEALED NO EVIDENCE OF THE LEAD PERFORATING THE MYOCARDIUM. THE PATIENT'S LEAD WAS REPOSITIONED WITH NO FURTHER ADVERSE EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXTEND IS-1 BI POSITIVE FIX IMPLANTABLE LEAD NVN CARDIAC PACEMAKERS, INC 4087 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention