BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 4131458 · Received October 1, 2014

    Report

    Report Number
    2124215-2014-14019
    Event Type
    Injury
    Date Received
    October 1, 2014
    Date of Event
    July 4, 2013
    Report Date
    July 21, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS LEAD IS SURGICALLY ABANDONED AND NO LONGER IN SERVICE. 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). THIS PATIENT¿S RV LEAD AND ICD ARE EXPECTED TO BE REPLACED SOON. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED CONCERNING THIS PROCEDURE AND/OR THE PRODUCTS GET RETURNED FOR ANALYSIS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV) LEAD AND IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED A HIGH SHOCK IMPEDANCE MEASUREMENT OF GREATER THAN 125 OHMS SOMETIME IN THE PAST YEAR. ALL OTHER RV LEAD PARAMETERS WERE NORMAL. ADDITIONAL INFORMATION FROM THE FIELD INDICATED THAT THE CAUSE OF THE HIGH MEASUREMENT WAS UNKNOWN. THE PATIENT IS BEING SCHEDULED TO HAVE A REPLACEMENT PROCEDURE FOR A NEW ICD AND RV LEAD, BUT FOR NOW THE SYSTEM CONTINUES TO REMAIN IMPLANTED AND IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION MADE AVAILABLE FROM THE FIELD INDICATED THAT THERE WAS ALSO A GRADUAL RISE IN PACING IMPEDANCE MEASUREMENTS, BUT NOTHING OUT OF RANGE. INTERVENTION WAS PERFORMED AND THE RV LEAD WAS SURGICALLY ABANDONED WHILE THE ICD WAS EXPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    610460 ENDOTAK RELIANCE IMPLANTABLE LEAD LWS CPI - DEL CARIBE 0165

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R T175| 0165