BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3252013 · Received July 29, 2013

    Report

    Report Number
    2124215-2013-09769
    Event Type
    Malfunction
    Date Received
    July 29, 2013
    Date of Event
    May 24, 2013
    Report Date
    July 15, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, VISUAL OBSERVATION REVEALED THAT THE COMPLETE LEAD WAS RETURNED WITH BODY FLUID NOTED IN THE HELIX HOUSING. THE TIP AND HELIX APPEAR INTACT AND NO DISCERNIBLE SETSCREW MARKS WERE NOTED. PRODUCT ANALYSIS COULD NOT CONFIRM THE ALLEGATION OF AN RV LEAD DISLODGMENT. THE LEAD PASSED ELECTRICAL TESTING AND THE LEAD TIP AND HELIX HAVE NO VISIBLE SIGNS OF DAMAGED WHICH COULD LEAD TO DISLODGMENT. FURTHERMORE, ANALYSIS OBSERVED THAT THE LEAD WAS NON-CLINICALLY OUT OF SPECIFICATION AS INDUCED IN THE FIELD DURING EXPLANT PROCEDURE.

    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 THIS RIGHT VENTRICULAR (RV) LEAD AND IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DISPLAYED OUT-OF-RANGE (OOR) SHOCK IMPEDANCES THAT WERE DETECTED VIA THE PATIENT¿S REMOTE HOME MONITORING SYSTEM. ALL OTHER MEASUREMENTS WERE STABLE AND NO OVERSENSING WAS OBSERVED. THE FIELD REPRESENTATIVE DISCUSSED THE PROBABILITY OF ELECTROMAGNETIC INTERFERENCE (EMI) OR LEAD ISSUE. THE SYSTEM REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT A REVISION PROCEDURE WAS PERFORMED DUE TO AN ALLEGED RV LEAD DISLODGEMENT ASSOCIATED WITH INCREASED THRESHOLD, LOW R-WAVE AMPLITUDE AND A SLIGHT DECREASE IN IMPEDANCE MEASUREMENTS. THE RV LEAD WAS EXPLANTED AND SUCCESSFULLY REPLACED.

    Description of Event or Problem · 1

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    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    354181 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0180

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR 0064| MISMATCH| E161| 0180| 1857| 6937A