BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 4131674 · Received October 1, 2014

    Report

    Report Number
    2124215-2014-15816
    Event Type
    Injury
    Date Received
    October 1, 2014
    Date of Event
    July 11, 2014
    Report Date
    July 11, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    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 THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND RIGHT VENTRICULAR (RV) LEAD EXHIBITED OVERSENSING AND DECREASED IMPEDANCE NUMBERS IN THE FEW WEEKS FOLLOWING IMPLANT. ARTIFACTS WERE NOTED ON THE RV LEAD DURING NON SUSTAINED EPISODES. AN X-RAY WAS TAKEN HOWEVER, THERE DID NOT APPEAR TO BE ANY CHANGE IN THE LEAD LOCATION. THE ISSUES WERE DISCOVERED WHEN THE PATIENT CAME TO THE HOSPITAL AFTER EXPERIENCING SYNCOPE. THE RV LEAD HAS BEEN EXPLANTED AND A NEW RV LEAD IMPLANTED WITHOUT ISSUE. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    612140 ENDOTAK RELIANCE NVY CPI - DEL CARIBE 0293

    Patients

    Seq Age Sex Outcome Treatment
    1 10382 DA Hospitalization| L| R 4076| 0293| E162