BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 4150840 · Received October 8, 2014

    Report

    Report Number
    2124215-2014-17307
    Event Type
    Injury
    Date Received
    October 8, 2014
    Date of Event
    August 27, 2014
    Report Date
    August 28, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    LWS
    PMA / PMN Number
    P910073
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 A PATIENT WITH AN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS IN THE HOSPITAL DUE TO SHOCK RECEIVED. THE PATIENT WAS DANCING WHEN THE SHOCK WAS DELIVERED; HOWEVER, THERE WAS NO THERAPY EXHAUSTION REPORTED. UPON DEVICE INTERROGATION, AN ERROR CODE WAS DETECTED. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) DISCUSSED THAT AN ERROR CODE IS LIKELY AN INDICATION OF A LEAD FRACTURE. FURTHER, THE FIELD REPRESENTATIVE INDICATED THAT THERE WERE STORED EVENTS WHICH SHOWED NOISE ON RATE AND SHOCK ELECTROGRAMS (EGMS). THE NOISE BEING OVERSENSED DID NOT LED TO PACING INHIBITION. ALSO, THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH OUT-OF-RANGE (OOR) PACING IMPEDANCE GREATER THAN 2,000 OHMS AND HIGH OOR SHOCK IMPEDANCE OF GREATER THAN 200 OHMS. TS DISCUSSED TROUBLESHOOTING OPTIONS. ADDITIONAL INFORMATION RECEIVED THAT THE LEAD HAD A FRACTURE DETERMINED UPON VISUALIZATION AND CONFIRMED THROUGH A PACING SYSTEM ANALYZER (PSA). THE RV LEAD WAS SURGICALLY ABANDONED AND NO LONGER IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    633080 ENDOTAK RELIANCE IMPLANTABLE LEAD LWS CPI - DEL CARIBE 0180

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Hospitalization| L| R E110| 4469| 0180