BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXTEND

    MDR report key: 1951589 · Received January 6, 2011

    Report

    Report Number
    2124215-2010-23452
    Event Type
    Injury
    Date Received
    January 6, 2011
    Date of Event
    November 24, 2010
    Report Date
    July 28, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, IT WAS NOTED THAT THE COMPLETE LEAD WAS RETURNED WITH THE HELIX RETRACTED AND THE STYLET INSIDE OF THE LEAD. VISUAL INSPECTION REVEALED THAT THE CONDUCTOR COILS WERE DEFORMED AT 217 MM FROM THE TERMINAL PIN AND THERE WERE CUTS IN THE SILICONE INSULATION AT 261 TO 263 MM FROM THE TERMINAL PIN. FURTHER VISUAL INSPECTION NOTED THAT THE INSULATION BETWEEN THE ANODE RING AND HELIX HOUSING WAS TWISTED AND LEAD ON LEAD ABRASION COULD BE SEEN AT 238 TO 245 MM FROM THE TERMINAL PIN. DURING TESTING, THE HELIX WOULD NOT EXTEND WHICH WAS DETERMINED TO BE MOST LIKELY DUE TO DRIED BLOOD IN THE HELIX MECHANISM UP THROUGH THE LUMEN AND DRIED BODY TISSUE ENTWINED IN THE HELIX AND HELIX HOUSING. THE INTERMITTENT CAPTURE, HIGH THRESHOLD MEASUREMENTS AND DISLODGEMENT ALLEGATIONS WERE NOT ABLE TO BE CONFIRMED BY ANALYSIS. HOWEVER, ANALYSIS DID CONFIRM THE ALLEGATION THAT THE HELIX WOULD NOT EXTEND.

    Additional Manufacturer Narrative · 1

    NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    NEW INFORMATION WAS RECEIVED THAT A LEAD REVISION PROCEDURE WAS PERFORMED SEVEN MONTHS LATER DUE TO RA AND RV LEAD DISLODGEMENT. THE RA LEAD WAS SUCCESSFULLY REPOSITIONED AND REMAINS IMPLANTED IN THE PATIENT. HOWEVER, WHILE ATTEMPTING TO REPOSITION THE RV LEAD, THE HELIX WOULD NO LONGER EXTEND. THE RV LEAD WAS EXPLANTED AND A NEW LEAD WAS SUCCESSFULLY IMPLANTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED AS A RESULT OF THE LEAD REVISION PROCEDURE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THREE MONTHS POST IMPLANT IT WAS NOTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED INTERMITTENT CAPTURE AT HIGH OUTPUT MEASUREMENTS. THE PATIENT WAS IN THE HOSPITAL FOR A CARDIOVERSION DUE TO ATRIAL FIBRILLATION. POST CARDIOVERSION, A SIMILAR PATTERN OF LOSS OF CAPTURE WITH HIGH THRESHOLD MEASUREMENTS ON THE RIGHT ATRIAL (RA) LEAD WAS OBSERVED. EXIT BLOCK IS SUSPECTED. THE PATIENT IS NOT PACEMAKER DEPENDENT. THE BOSTON SCIENTIFIC SALES REPRESENTATIVE STATED THAT THERE WAS NO PACING FROM THE LEADS AND THE PHYSICIAN HAS PLACED THE PATIENT ON ORAL MEDICATION IN AN ATTEMPT TO DECREASE THE EXIT BLOCK. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED AND THE INVESTIGATION IS COMPLETE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXTEND IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4087

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization| L| R 4087| 4086| S603