BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXTEND

    MDR report key: 3053381 · Received April 11, 2013

    Report

    Report Number
    2124215-2013-04825
    Event Type
    Injury
    Date Received
    April 11, 2013
    Date of Event
    March 18, 2013
    Report Date
    May 6, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    PMA / PMN Number
    P960006
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS TIME, THE PRODUCT HAS NOT BEEN RETURNED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE TO OUR COMPANY, THIS EVENT WOULD BE UPDATED.

    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 EXTENDED AND TISSUE ENTWINED IN THE HELIX. VISUAL INSPECTION REVEALED DEFORMED CONDUCTOR COILS ALONG WITH PUNCTURE HOLES IN THE INSULATION AT 196 TO 198 MM FROM THE TERMINAL PIN, WHICH WAS DETERMINED TO BE MOST LIKELY FROM SOME TYPE OF GRABBING TOOL. THE LEAD TIP AND HELIX HAVE NO VISIBLE SIGNS OF DAMAGE OR DEFECT WHICH WOULD LEAD TO DISLODGEMENT, THUS ANALYSIS WAS UNABLE TO CONFIRM THE ALLEGATION FROM THE FIELD. THE LEAD WAS SUBJECT TO DIRECT CURRENT RESISTANCE TESTING AND PASSED ON ALL PATHS, VERIFYING THE LEAD'S ELECTRICAL PERFORMANCE WAS INTACT. NO FURTHER TESTING WAS PERFORMED.

    Description of Event or Problem · 1

    --

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE RIGHT ATRIAL (RA) AND RIGHT VENTRICULAR (RV) LEADS EXHIBITED LOSS OF CAPTURE DUE TO DISLODGEMENT. SUBSEQUENTLY A REVISION PROCEDURE WAS PERFORMED WHERE BOTH LEADS WERE EXPLANTED AND NEW LEADS WERE SUCCESSFULLY IMPLANTED. A PARSONNET POUCH WAS APPLIED AROUND THE EXISTING PACEMAKER IN ORDER TO HOPEFULLY PREVENT FUTURE DISLODGEMENTS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156555 FLEXTEND IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4088

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Hospitalization| L| R 4087| 4088| K173