BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 1950521 · Received January 6, 2011

    Report

    Report Number
    2124215-2010-22775
    Event Type
    Malfunction
    Date Received
    January 6, 2011
    Date of Event
    November 17, 2010
    Report Date
    November 17, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    ALL AVAILABLE INFORMATION INDICATES THAT THIS PRODUCT REMAINS IN SERVICE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS TRANSVENOUS DEFIBRILLATION LEAD EXHIBITED EPISODES OF NOISE ON THE RIGHT VENTRICULAR (RV) CHANNEL, WHICH WAS OVERSENSED AND RESULTED IN 3 TO 5 SECOND PAUSES IN PACING. THERE WAS A SMALL AMOUNT OF NOISE ON THE SHOCK CHANNEL. NORMAL PACING VALUES WERE OTHERWISE NOTED. DEVICE MEMORY WAS SAVED TO A DISK AND RETURNED. ENGINEERING REVIEW OF THE DEVICE MEMORY NOTED OVERSENSING OF EXTERNAL NOISE AND THE PRESENCE OF A MAGNET OVER THE DEVICE AT THE TIME OF THE EPISODES. THEY ADVISED TO INQUIRE IF THE PATIENT HAD A PROCEDURE THAT DAY, AS THE NOISE MIGHT BE DUE TO ELECTROCAUTERY. IT WAS ALSO NOTED THAT THE SHOCK CHANNEL RECORDED WHAT APPEARED TO BE PATIENT VENTRICULAR FIBRILLATION (VF) OR PAROXYSMAL VENTRICULAR TACHYCARDIA (PVT). IT WAS THEN REPORTED THAT THERE HAD BEEN EPISODES OF NOISE ON THE RV CHANNEL WITH ISOMETRICS PRIOR TO THIS; HOWEVER, THERE WERE NO EPISODES IN THE ARRHYTHMIA LOGBOOK. IT WAS NOTED THAT THE PATIENT WOULD BE BROUGHT BACK IN TO THE CLINIC FOR FURTHER EVALUATION. TO DATE, THERE HAVE BEEN NO REPORTED ADVERSE PATIENT EFFECTS RELATED TO THIS CLINICAL OBSERVATION. ADDITIONAL INFORMATION WAS PROVIDED THAT THE PATIENT WAS HAVING A SKIN CANCER REMOVAL WHEN THE PAUSES OCCURRED. THUS, EXTERNAL NOISE WAS THE CAUSE OF THE INHIBITION OF PACING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0184

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR MISMATCH| N119| 0184| 1488TC| 4555