BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3043341 · Received April 9, 2013

    Report

    Report Number
    2124215-2013-04642
    Event Type
    Injury
    Date Received
    April 9, 2013
    Date of Event
    January 26, 2013
    Report Date
    June 28, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AVAILABLE INFORMATION INDICATES THAT THIS PRODUCT REMAINS IMPLANTED AND IN SERVICE. 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, VISUAL INSPECTION IDENTIFIED SETSCREW MARKS ON THE IS-1 AND THE DISTAL HIGH VOLTAGE TERMINAL PINS. SEVERAL INSULATION CUTS WERE NOTED WHICH IS CONSISTENT WITH THE TYPE OF DAMAGE THAT CAN OCCUR AT THE EXPLANT PROCEDURE. BODILY FLUID WAS FOUND IN THE RS (NEGATIVE) DUE TO INSULATION DAMAGE (CUT) AND IN THE HELIX HOUSING. THE LEAD WAS PUT THROUGH AND PASSED ELECTRICAL CONTINUITY TESTING.

    Description of Event or Problem · 1

    SUBSEQUENTLY, BOSTON SCIENTIFIC RECEIVED INFORMATION IN (B)(6) 2013 THAT THIS PHYSICIAN CONTACTED THE LOCAL REPRESENTATIVE TO REPORT THAT THIS PATIENT HAD DIED IN (B)(6) 2013. THE CAUSE OF DEATH WAS NOT KNOWN AND THE PHYSICIAN WAS INTERESTED IN HAVING THE STORED DATA FROM THE DEVICE REVIEWED. TO DATE, THE LEAD HAS NOT BEEN RECEIVED AT BOSTON SCIENTIFIC. THE LAST KNOWN DATA UPLOAD FROM THE PATIENT'S MONITORING SYSTEM OCCURRED BACK IN 2009 FROM THE PATIENT'S PREVIOUS DEVICE. A NEW COMMUNICATOR WAS SHIPPED FOLLOWING THE PATIENT'S DEVICE REPLACEMENT PROCEDURE. HOWEVER, THE COMMUNICATOR WAS NEVER SET-UP BY THE PATIENT UPON DELIVERY. BOSTON SCIENTIFIC RECEIVED ADDITIONAL INFORMATION THAT THE MANNER OF DEATH WAS LISTED AS "NATURAL". THE PATIENT HAD A MEDICAL HISTORY OF HEART DISEASE, DIABETES AND HIGH CHOLESTEROL. ON THE DATE OF DEATH, THE PATIENT HAD UNDERGONE A TEE CARDIOVERSION. THE PATIENT HAD BEEN DISCHARGED AND COLLAPSED WHILE AT HOME. THE PATIENT WAS ASSISTED BACK INTO BED AND WAS FOUND UNRESPONSIVE SHORTLY THEREAFTER. THE PATIENT WAS TRANSPORTED TO THE HOSPITAL AND WAS DECLARED DEAD.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE DEFIBRILLATION LEAD DISLODGED ONE DAY POST IMPLANT. A REVISION PROCEDURE WAS PERFORMED. THE LEAD WAS SUCCESSFULLY REPOSITIONED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    147506 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0181

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| L| R 0181| E143| 4470| 0174| T165