BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 4139973 · Received October 3, 2014

    Report

    Report Number
    2124215-2014-16619
    Event Type
    Injury
    Date Received
    October 3, 2014
    Date of Event
    September 4, 2014
    Report Date
    September 23, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    LWS
    PMA / PMN Number
    P910073
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Additional Manufacturer Narrative · 1

    (B)(4). UPON RETURN, THIS LEAD WAS THOROUGHLY ANALYZED. VISUAL EXAMINATION CONFIRMED A COMPLETE INTACT LEAD WITH SETSCREW MARKS ON THE IS-1 DISTAL HIGH VOLTAGE TERMINAL PINS; HOWEVER, NO DISCERNABLE SETSCREW MARKS WERE OBSERVED ON THE IS-1, RING. THE HELIX COIL EXHIBITED ENTWINED TISSUE AND WAS STRETCHED FROM ITS ORIGINAL SHAPE; BLOOD AND/OR BODY FLUID WAS OBSERVED IN AND AROUND THE HELIX HOUSING. THE RETURNED LEAD REVEALED NO INSULATION BREACHES. EXTENSIVE TESTING WAS THEN PERFORMED TO ASSESS THE LEAD'S ELECTRICAL AND INSULATION INTEGRITY. MEASUREMENTS THROUGHOUT THESE TESTS DEMONSTRATED CONTINUITY OF THE ELECTRICAL CIRCUITRY AND THE LEAD INSULATION. RIGOROUS TESTING, INCLUDING EXTENSIVE LEAD MANIPULATION WHILE CONNECTED TO AN OHMMETER, VERIFIED THERE WAS NO INTERMITTENCY IN THE ELECTRICAL CONDUCTIVITY. ANALYSIS CONCLUDED THAT THE LEAD WAS ELECTRICALLY CONTINUOUS AND DID NOT CONTRIBUTE TO THE OBSERVED CLINICAL OBSERVATIONS.

    Description of Event or Problem · 1

    SUBSEQUENTLY, THE LEAD WAS EXPLANTED AND RETURNED FOR LABORATORY ANALYSIS. ANOTHER BOSTON SCIENTIFIC LEAD WAS SUCCESSFULLY IMPLANTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A ROUTINE FOLLOW-UP, A SINGLE HIGH OUT OF RANGE RIGHT VENTRICULAR PACING IMPEDANCE MEASUREMENT WAS NOTED. THE PHYSICIAN ATTEMPTED TO INDUCE ANOTHER HIGH VALUE WITH PATIENT MANIPULATION, HOWEVER NO ABNORMAL VALUES WERE DISPLAYED. ADDITIONALLY, A X-RAY IMAGING FAILED TO SHOW ANY SYSTEM ANOMALIES. ALL OTHER SYSTEM MEASUREMENTS WERE NORMAL AND STABLE. ALTHOUGH ROOT CAUSE WAS NOT DETERMINED, THE PATIENT WAS RELEASED FOR NORMAL FOLLOW-UP. SHOULD NEW INFORMATION BE PROVIDED, THIS EVENT WILL BE REOPENED AND FURTHER INVESTIGATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    619535 ENDOTAK RELIANCE IMPLANTABLE LEAD LWS CPI - DEL CARIBE 0181

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R MISMATCH| 0181| D047