BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK C

    MDR report key: 3790185 · Received May 5, 2014

    Report

    Report Number
    2124215-2014-09405
    Event Type
    Injury
    Date Received
    May 5, 2014
    Date of Event
    January 11, 2014
    Report Date
    March 30, 2014
    Manufacturer
    HISTORICAL CPI ST. PAUL
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS. 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 THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND RIGHT VENTRICULAR (RV) LEAD EXHIBITED LOW OUT OF RANGE PACING LEAD IMPEDANCE MEASUREMENTS LESS THAN 200 OHMS. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) CHECKED THE REMOTE MONITORING SYSTEM AND DETERMINED CHANGES IN PACE IMPEDANCE TREND FROM 400S TO LESS THAN 200 OHMS. ALSO, NUMEROUS NON-SUSTAINED EVENTS WERE NOTED WITH NOISE ON THE RV RATE SENSE. ADDITIONAL INFORMATION INDICATED THAT THE LEAD WAS NOT VIEWED UNDER FLUOROSCOPY NOR TESTED ON A PACING SYSTEM ANALYZER (PSA). MOREOVER, OVERSENSED NOISE DID NOT LEAD TO PACING INHIBITION OF MORE THAN 2 SECONDS. THE ICD WAS EXPLANTED WHILE THE RV LEAD WAS ABANDONED SURGICALLY. THE ICD AND RV LEAD WERE NO LONGER IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    266729 ENDOTAK C IMPLANTABLE LEAD LWS HISTORICAL CPI ST. PAUL 0064

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| L| R 1746| 1857| E141| 6931| 6162| 1705| 0064