BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3210810 · Received July 8, 2013

    Report

    Report Number
    2124215-2013-07207
    Event Type
    Injury
    Date Received
    July 8, 2013
    Date of Event
    April 29, 2013
    Report Date
    June 18, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE THE EXPLANTE DEVICE AND LEAD HAVE NOT BEEN RECEIVED AT BOSTON SCIENTIFIC. UPON RECEIPT THE PRODCUTS WILL UNDERGO DETAILED ANLAYSIS IN AN ATTEMPT TO CONFIRM AND DETERMINE THE ROOT CAUSE OF THIS EVENT.

    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 SET SCREW MARKS ON THE TERMINAL PIN. NO DAMAGES WERE FOUND ON THE TERMINAL CONNECTOR OF THE LEAD. LABORATORY TESTING WAS UNABLE TO REPRODUCE THE REPORTED CLINICAL OBSERVATIONS AND DETAILED ANALYSIS DID NOT REVEAL ANY ABNORMALITIES.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING AN IMPLANT PROCEDURE, WHILE PERFORMING DEVICE TESTING THIS RIGHT VENTRICULAR (RV) LEAD REVEALED NOISE AND OVERSENSING. THE LEAD WAS THEN UNSCREWED FROM THE DEVICE AND RECONNECTED HOWEVER NOISE AND OVERSENSING CONTINUED TO OCCUR. THE LEAD WAS REPOSITIONED AND REMAIN OUT OF RANGE. THE LEAD WAS THEN EXPLANTED AND REPLACED,HOWEVER THE NEW LEAD REVEALED MANY NOISE AS WELL. THE FINAL DECISON WAS MADE TO REPLACED THE DEVICE. UPON VISUAL INSPECTION OF THE DEVICE THE SET SCREW SEALINGS APPEARED TO BE DEFECTIVE. A BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) CONSULTANT WAS CONTACTED. THE DEVICE AND LEAD WERE RETURNED FOR ANLAYSIS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309009 ENDOTAK RELIANCE NVY CPI - DEL CARIBE 0295

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening