BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3050052 · Received April 10, 2013

    Report

    Report Number
    2124215-2013-04259
    Event Type
    Malfunction
    Date Received
    April 10, 2013
    Date of Event
    February 18, 2013
    Report Date
    June 18, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    LWS
    PMA / PMN Number
    P910073
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    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 ONLY THREE SEGMENTS OF TERMINAL CONNECTOR WERE RETURNED. ALL THREE SEGMENTS WERE SEVERED FROM THE TERMINAL PIN. ALL OF THE LEAD SEGMENTS WERE SUBJECT TO DIRECT CURRENT RESISTANCE TESTING AND PASSED ON ALL PATHS, VERIFYING ELECTRICAL PERFORMANCE WAS INTACT FOR THE PORTION OF THE LEAD THAT WAS RETURNED. NO FURTHER TESTING WAS PERFORMED ANALYSIS COULD NOT CONFIRM THE CLINICAL ALLEGATIONS OBSERVED IN THE FIELD AS THE ENTIRE LEAD WAS NOT RETURNED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A ROUTINE INTERROGATION, THE CLINICIAN NOTED ONE STORED VENTRICULAR EPISODE WITH NOISE ON RIGHT VENTRICULAR (RV) AND SHOCK CHANNELS. PACING WAS INHIBITED FOR ABOUT FOUR SECONDS TO AN ESCAPE RATE OF AROUND 30 BPM. IT WAS NOTED THAT THE PATIENT WAS ASYMPTOMATIC AND WAS UNAWARE OF WHAT HE WAS DOING AT THE TIME OF THE EPISODE. ISOMETRICS WERE NEGATIVE FOR RV NOISE, HOWEVER THERE WAS NOISE ON THE SHOCK CHANNEL. THE SENSITIVITY WAS PROGRAMMED TO 0.8MV AND THEY WILL CONTINUE NORMAL THREE MONTH FOLLOW-UPS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT AT LEAST A PORTION OF THIS LEAD WAS EXPLANTED FOLLOWING THE PATIENT'S DEATH. THREE PORTIONS WERE RETURNED FOR ANALYSIS. THERE WERE NO DEVICE ALLEGATIONS RELATING TO THE PATIENT'S DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    153195 ENDOTAK RELIANCE IMPLANTABLE LEAD LWS CPI - DEL CARIBE 0158

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR H170| 4087| 0158| 1861| N119| 4538