BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3930013 · Received July 11, 2014

    Report

    Report Number
    2124215-2014-13725
    Event Type
    Injury
    Date Received
    July 11, 2014
    Date of Event
    April 21, 2014
    Report Date
    May 6, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    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 VIA THE PATIENT'S REMOTE MONITORING SYSTEM THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WITH THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH OUT-OF-RANGE (OOR) PACING LEAD IMPEDANCE OF GREATER THAN 2,000 OHMS AND HAD NO CAPTURE AT MAXIMUM OUTPUT. NO ASYSTOLE OF GREATER THAN 2 SECONDS WAS REPORTED. FURTHER, THE FIELD REPRESENTATIVE INDICATED THAT THE RV LEAD WAS CHECKED AND NO VISIBLE DAMAGE WAS NOTED. THE PHYSICIAN IMPLANTED A NEW RATE/SENSE LEAD. ADDITIONAL INFORMATION RECEIVED THAT THE PATIENT WAS NEVER PACED. FURTHER INFORMATION WAS RECEIVED THAT THE RATE/SENSE PORTION OF LEAD WAS TESTED ON A PACING SYSTEM ANALYZER (PSA) AND SAME RESULTS WERE OBSERVED AND NOTHING WORKED. THE SHOCK PORTION OF THE LEAD REMAINS IN SERVICE AND THE RATE/SENSE PORTION OF THE LEAD WAS SURGICALLY ABANDONED. THE ICD REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    407522 ENDOTAK RELIANCE IMPLANTABLE LEAD LWS CPI - DEL CARIBE 0157

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| L| R T125| E143| 4469| 0157