BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2163454 · Received July 15, 2011

    Report

    Report Number
    2124215-2011-08522
    Event Type
    Injury
    Date Received
    July 15, 2011
    Date of Event
    April 21, 2011
    Report Date
    April 21, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT WITH THIS IMPLANTED RIGHT VENTRICULAR (RV) LEAD WAS HOSPITALIZED AFTER PRESENTING TO AN EMERGENCY ROOM AFTER RECEIVING NUMEROUS INAPPROPRIATE SHOCKS. THE LEAD HAD A RECENT HISTORY OF LOW PACE IMPEDANCE MEASUREMENTS, AND A BOSTON SCIENTIFIC TECHNICAL SERVICES CONSULTANT (TS) DISCUSSED THE POSSIBILITY OF A LEAD INSULATION ISSUE. IT WAS REPORTED THAT A PACING THRESHOLD COULD NOT BE OBTAINED DURING FOLLOW-UP TESTING, AND THERE WAS EVIDENCE OF INTERMITTENT UNDERSENSING. DURING CLINICAL ISOMETRIC EXERCISES, THE LEAD ALSO EXHIBITED INTERMITTENT OVERSENSING. THE SHOCK IMPEDANCE MEASUREMENTS WERE NORMAL AND STABLE. THE ASSOCIATED DEVICE'S TACHYCARDIA THERAPIES WERE PROGRAMMED OFF AFTER THE PATIENT WAS ADMITTED FOR PENDING ADDITIONAL INVESTIGATION. THE LEAD SUBSEQUENTLY WAS CAPPED AND SURGICALLY ABANDONED, AND ANOTHER MANUFACTURER'S LEAD WAS IMPLANTED. LEAD CLAVICULAR CRUSH WAS SUSPECTED. NO OTHER 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 0157

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization| R 1860| 0157