BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2173307 · Received July 23, 2011

    Report

    Report Number
    2124215-2011-10593
    Event Type
    Injury
    Date Received
    July 23, 2011
    Date of Event
    June 15, 2011
    Report Date
    June 15, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS TIME THE LEAD HAS NOT BEEN RETURNED TO BOSTON SCIENTIFIC 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 DEVICE SYSTEM DISPLAYED NOISE ON THE RIGHT VENTRICULAR (RV) CHANNEL WHEN THE PATIENT MOVED HIS ARM. A LOOSE DEVICE HEADER WAS SUSPECTED, HOWEVER, NOT CONFIRMED. AN INVASIVE REVISION PROCEDURE WAS PERFORMED, AND UNDER FLUOROSCOPY, THE RV LEAD APPEARED TO BE FRACTURED. ADDITIONALLY, THE RIGHT ATRIAL (RA) LEAD APPEARED TO BE COMPROMISED. ONCE EXPLANTED, THE DEVICE DID NOT APPEAR TO BE DAMAGED. RV IMPEDANCE MEASUREMENTS WERE OUT OF RANGE AND THE RV AND RA LEADS WERE SURGICALLY ABANDONED AND WERE SURGICALLY REMOVED AT A LATER DATE. NO ADVERSE PATIENT EFFECTS WERE REPORTED DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0158

    Patients

    Seq Age Sex Outcome Treatment
    1 288 MO Hospitalization| R E110| 0158| 6949| (B)(4)| 4136