BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2153489 · Received July 7, 2011

    Report

    Report Number
    2124215-2011-10657
    Event Type
    Injury
    Date Received
    July 7, 2011
    Date of Event
    April 6, 2011
    Report Date
    April 6, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE LEAD WAS PERFORMED. AN X-RAY OF THE LEAD REVEALED THAT THE CONDUCTOR WIRES OF THE PROXIMAL SHOCKING COIL WERE FRACTURED APPROXIMATELY. DUE TO THE LOCATION AND SLIGHTLY FLATTENED APPEARANCE OF THE PROXIMAL SHOCKING COIL ADJACENT TO THE FRACTURE SITE SUGGESTED THAT THE LEAD MAY HAVE BEEN DISLODGED INTO THE CLAVICLE FIRST RIB AREA AND MAY HAVE SUFFERED A FRACTURE FROM CLAVICLE FIRST/RIB ENTRAPMENT. BOTH OF THE FRACTURED WIRES OF THE SHOCKING COIL REVEALED EVIDENCE OF FATIGUE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR DEFIBRILLATION LEAD HAD BEEN EXHIBITING HIGH SHOCK IMPEDANCES OVER THE PAST FEW MONTHS. TESTING WAS PERFORMED WITH THE LEAD AND IT WAS FELT THAT THE ISSUE WAS DUE TO A DAMAGED PROXIMAL COIL. A REVISION PROCEDURE WAS PERFORMED. DURING THE PROCEDURE, IT WAS NOTED THAT THE PROXIMAL COIL OF THE LEAD WAS DAMAGED. THE LEAD WAS REMOVED AND REPLACED. DURING THE SAME PROCEDURE IT WAS ELECTED TO REMOVE AND REPLACE THE DEVICE; THERE WERE NO ALLEGATIONS AGAINST THE DEVICE. THE EXPLANTED LEAD WAS RETURNED FOR ANALYSIS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0185

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R