BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3232032 · Received July 17, 2013

    Report

    Report Number
    2124215-2013-11369
    Event Type
    Injury
    Date Received
    July 17, 2013
    Date of Event
    April 21, 2013
    Report Date
    April 21, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    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 THE PATIENT WITH THIS RIGHT VENTRICULAR (RV) LEAD WAS TRANSFERRED TO A DIFFERENT HEALTH CARE FACILITY DUE TO NEW ONSET OF ATRIAL FIBRILLATION. A CARDIOVERSION FOR THE ATRIAL FIBRILLATION WAS PLANNED AND AT THAT TIME IT WAS NOTED THE RV CAPTURE THRESHOLD WAS ELEVATED, AND THAT THE PATIENT HAD A PERICARDIAL EFFUSION. IT WAS SUSPECTED THAT THE LEAD HAD PERFORATED AND MIGRATED OUT INTO THE PERICARDIAL SAC. SURGICAL INTERVENTION WAS PERFORMED, AND THE SURGEON CREATED A PERICARDIAL WINDOW. AFTER OBTAINING ACCESS, THE PHYSICIAN DETERMINED THE LEAD HAD PERFORATED, BUT HAD HEALED AND WAS NOT LEAKING ANY LONGER. IT WAS DECIDED LEAVE THE LEAD IN THE CURRENT POSITION, AS THE SURGEON AND CARDIOLOGIST THOUGHT IT WAS LESS RISKY THAN ATTEMPTING TO REPOSITION IT. DEFIBRILLATION THRESHOLD (DFT) TESTING WAS PERFORMED AND SUCCESSFUL AT 31 JOULES WITH A 35 OHM SHOCK LEAD IMPEDANCE. THE RV THRESHOLDS REMAINED HIGH AT HIGH 4 VOLTS. ON FOLLOW-UP EVALUATION, APPROXIMATELY TWO MONTHS LATER, THE RV THRESHOLD WAS 2.1 VOLTS. THE SYSTEM REMAINS IN SERVICE AND NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332627 ENDOTAK RELIANCE NVY CPI - DEL CARIBE 0296

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| L| R S602| 4592| 4469| N160| 4457| 4555| 0296