BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 1953718 · Received January 10, 2011

    Report

    Report Number
    2124215-2010-24337
    Event Type
    Injury
    Date Received
    January 10, 2011
    Date of Event
    December 8, 2010
    Report Date
    December 12, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    LWS
    PMA / PMN Number
    P910073
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    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

    (B)(4). UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY IT WAS NOTED THAT ONLY THE RATE SENSE TERMINAL LEG WAS RETURNED AND WAS SEVERED AT 5.2 CM FROM TERMINAL PIN. RESISTANCE TESTS WERE COMPLETED TO ASSESS LEAD ELECTRICAL PERFORMANCE AND INSULATION INTEGRITY. MEASUREMENTS THROUGHOUT THESE TESTS WERE WITHIN NORMAL LIMITS. LABORATORY TESTING WAS UNABLE TO REPRODUCE THE REPORTED CLINICAL OBSERVATIONS AND DETAILED ANALYSIS DID NOT REVEAL ANY ABNORMALITIES. LABORATORY ANALYSIS DID NOT IDENTIFY ANY LEAD CHARACTERISTICS FROM THE RETURNED PORTION OF THE LEAD THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED CLINICAL OBSERVATIONS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT PRESENTED TO THE EMERGENCY ROOM WITH SYNCOPE FOR AN UNKNOWN REASON. UPON INTERROGATION, THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED UNDERSENSING DUE TO LOW AMPLITUDE MEASUREMENTS. THE RV SENSITIVITY WAS REPROGRAMMED TO 1.5 MV FROM 2 MV AND THE PHYSICIAN WILL BE CONSULTED FOR FURTHER MONITORING. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    A PORTION OF THE LEAD WAS EXPLANTED FOLLOWING THE PATIENT'S DEATH. THERE WERE NO ALLEGATIONS AGAINST RELATING TO THE PATIENT'S DEATH. THE DEVICE WAS RETURNED AND UNDERWENT ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE IMPLANTABLE LEAD LWS CPI - DEL CARIBE 0184

    Patients

    Seq Age Sex Outcome Treatment
    1 91 YR Hospitalization| L 0184| B301| 4469| S403