BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3052636 · Received April 11, 2013

    Report

    Report Number
    2124215-2013-04400
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Date of Event
    February 28, 2013
    Report Date
    March 28, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE LEAD WAS PERFORMED. RESISTANCE AND PRESSURE TESTS WERE COMPLETED TO ASSESS LEAD ELECTRICAL PERFORMANCE AND INSULATION INTEGRITY. MEASUREMENTS THROUGHOUT THESE TESTS WERE WITHIN NORMAL LIMITS. MICROSCOPIC INSPECTIONS OF THE TERMINAL PIN ASSEMBLY, LEAD BODY, AND ELECTRODE TIP FOUND NO ANOMALIES. LABORATORY TESTING WAS UNABLE TO REPRODUCE THE REPORTED CLINICAL OBSERVATIONS AND DETAILED ANALYSIS DID NOT REVEAL ANY ABNORMALITIES.

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS BEEN RECEIVED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON COMPLETION OF ANALYSIS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING THE IMPLANT PROCEDURE, WHEN CLOSING THE POCKETS OVERSENSING OF A PREMATURE VENTRICULAR CONTRACTION (PVC) ON THE RIGHT VENTRICULAR (RV) CHANNEL THAT LEAD TO PACING INHIBITION WITH LESS THAN TWO SECONDS OF ASYSTOLE WAS OBSERVED. CLOSURE OF THE POCKET WAS STOPPED AND THE DEVICE WAS REMOVED FROM THE POCKET AND THE LEAD WAS REMOVED FROM THE HEADER. THE PHYSICIAN THEN EXPERIENCED DIFFICULTY RE-INSERTING THE LEAD INTO THE DEVICE. THUS A NEW RV LEAD WAS IMPLANTED. HOWEVER THE OVERSENSING OF NOISE WORSENED. SEVERAL ATTEMPTS WERE MADE AT RE-INSERTING THE LEAD WITHOUT ANY CHANGE. SUBSEQUENTLY A NEW DEVICE WAS IMPLANTED AND NO OTHER ISSUES WERE OBSERVED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    155374 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0185

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR MISMATCH| E163| 0185