BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3905694 · Received July 1, 2014

    Report

    Report Number
    2124215-2014-11979
    Event Type
    Injury
    Date Received
    July 1, 2014
    Date of Event
    March 31, 2014
    Report Date
    May 15, 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 THAT ANOTHER MANUFACTURER'S FIELD REPRESENTATIVE REPORTED HIGH OUT OF RANGE SHOCK IMPEDANCE MEASUREMENTS FOR THE RIGHT VENTRICULAR (RV) LEAD AND COMPETITIVE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). SUBSEQUENTLY A REVISION PROCEDURE WAS PERFORMED WHERE THE PHYSICIAN FOUND THE PACE SENSE SET SCREW ON THE ICD TO NOT BE FULLY TIGHTENED. SINCE THE RV LEAD IS A BIPOLAR SENSING LEAD, IT EXHIBITED THE HIGH OUT OF RANGE SHOCK IMPEDANCE MEASUREMENTS. THE SETSCREW WAS TIGHTENED AND ALL SHOCK IMPEDANCE MEASUREMENTS WERE WITHIN NORMAL RANGE. THE RV LEAD AND ICD REMAIN IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    384969 ENDOTAK RELIANCE IMPLANTABLE LEAD LWS CPI - DEL CARIBE 0185

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization| L| R 4469| T165| 0185