BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3041238 · Received April 8, 2013

    Report

    Report Number
    2124215-2013-02964
    Event Type
    Injury
    Date Received
    April 8, 2013
    Date of Event
    December 13, 2012
    Report Date
    January 13, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY
    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.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS LOCAL REPRESENTATIVE COMMENTED THAT THIS PATIENT RECEIVED SHOCK THERAPY ON (B)(6) 2012. A REVIEW OF THE EPISODE IDENTIFIED NOISE ON THE ELECTROGRAM. TS SUGGESTED THAT LEAD DATA SHOULD BE EVALUATED TO DETERMINE IF ADDITIONAL INTERVENTION IS REQUIRED. THE LOCAL REPRESENTATIVE REVIEWED THE EPISODE AGAIN AND REPORTED THAT JUST PRIOR TO SHOCK DELIVERY, THE PATIENT WAS IN THE BATHROOM AND WAS BEARING DOWN. THE PATIENT BECAME 'CLAMMY' AND WAS PRE-SYNCOPAL. THE EPISODE WAS FURTHER DISCUSSED BY MEMBERS OF THE TS TEAM AND IN-HOUSE ENGINEERING. THE DEVICE HAD 17 EPISODES ON (B)(6) 2012. THREE OF THESE EPISODES PROVIDED ATP THERAPY AND ONE ALSO DELIVERED A 21J SHOCK. THEY ALL APPEAR TO HAVE NOISE ON BOTH THE VENTRICULAR AND SHOCK CHANNELS DURING THE EPISODES. SOME OF THE NOISE MAY HAVE CAUSED OVERSENSING ALTHOUGH THE EPISODE WITH THE SHOCK APPEARS TO HAVE A FAST INTRINSIC RATE. THE DEVICE ALSO RECORDED A LEAKAGE ON LEAD FAULT THIS TYPE OF FAULT MAY BE CAUSED BY THE DEVICE DETECTING ENERGY FROM AN EXTERNAL SOURCE. IT WAS CONCLUDED THAT THIS 12-YEAR OLD LEAD SHOULD BE THOROUGHLY EVALUATED. SUBSEQUENTLY, BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATIENT WAS PRESENTED TO THE ELECTROPHYSIOLOGY (EP) LABORATORY. THE RV PACE/SENSE TERMINAL PIN WAS SURGICALLY CAPPED. A SEPARATE RV PACE/SENSE LEAD WAS SUCCESSFULLY IMPLANTED. THE SHOCK PORTION OF THE RV DEFIBRILLATION LEAD REMAINS IN-SERVICE. THE LOCAL REPRESENTATIVE WAS NOT SURE IF THERE HAD BEEN ASYSTOLE FOR GREATER THAN TWO SECONDS. WHEN THE POCKET WAS OPENED, VISUAL INSPECTION OF THE PROXIMAL PORTION OF THE LEAD DID NOT IDENTIFY ANY INSULATION DISCONFORMITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143751 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0147

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| L| R E102| 1860| 0147