BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3092545 · Received May 3, 2013

    Report

    Report Number
    2124215-2013-06384
    Event Type
    Injury
    Date Received
    May 3, 2013
    Date of Event
    February 11, 2013
    Report Date
    March 11, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE
    Reporter Occupation
    PHYSICIAN

    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, A THOROUGH EVALUATION OF THE LEAD WAS PERFORMED. VISUAL INSPECTION OF THE LEAD REVEALED A SEPARATION OF THE GORE WHERE DISTAL SHOCKING COIL IS EXPOSED AT DISTAL REGION. ASSOCIATED WITH THIS WAS A FULL RETRACTION OF THE HELIX. TISSUES ENTWINED IN THE HELIX WAS ALSO OBSERVED. THE SEPARATION WAS A RESULT OF EXCESSIVE DRAG ON THE GORE AND THE SHOCKING COILS. NO IRREGULARITIES WERE NOTED AT THE TIP REGION OF THE LEAD. UNDER NORMAL CIRCUMSTANCES, SEPARATION OF THE GORE COVERING WILL NOT IMPACT THE FUNCTIONALITY OF THE LEAD.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV) LEAD HAD DISLODGED. DURING REPOSITIONING OF THE LEAD, IT WAS NOTED THAT SOME OF THE GORE COATING ON THE SHOCKING COIL WAS SLIGHTLY EXPOSED. THIS LEAD WAS EXPLANTED. A REPLACEMENT LEAD WAS SUCCESSFULLY IMPLANTED IN THE PATIENT. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    193987 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0184

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization| L| R E141| 0184