BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3904738 · Received July 1, 2014

    Report

    Report Number
    2124215-2014-10366
    Event Type
    Malfunction
    Date Received
    July 1, 2014
    Date of Event
    April 4, 2014
    Report Date
    December 19, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE LEAD WAS PERFORMED. THE COMPLETE LEAD WAS RETURNED. VISUAL INSPECTION OF THE LEAD REVEALED A SEPARATION OF THE GORE¿ COVERING FROM THE MEDICAL ADHESIVE (MA) AT THE PROXIMAL END OF THE PROXIMAL SHOCKING COIL. ASSOCIATED WITH THIS WAS A SLIGHT STRETCHING OF THE PROXIMAL END OF THIS SHOCKING COIL. RESISTANCE AND PRESSURE TESTS WERE COMPLETED TO ASSESS LEAD ELECTRICAL PERFORMANCE AND INSULATION INTEGRITY. MEASUREMENTS THROUGHOUT THESE TESTS WERE WITHIN NORMAL LIMITS. LABORATORY ANALYSIS WAS UNABLE TO CONFIRM THE FIELD OBSERVATIONS INCLUDING THAT THE LEAD HAD FRACTURED. THERE WAS NO FRACTURE FOUND ON THIS LEAD AND IT PASSED ALL ANALYSIS, INCLUDING ELECTRICAL CONTINUITY TESTING. THE ONLY ANOMALY FOUND DURING TESTING WAS THE STRETCHING OF THE PROXIMAL SHOCKING COIL. THE SEPARATION NOTED DURING ANALYSIS WAS A RESULT OF EXCESSIVE DRAG ON THE GORE AND THE SHOCKING COILS. UNDER NORMAL CIRCUMSTANCES, SEPARATION OF THE GORE COVERING WILL NOT IMPACT THE FUNCTIONALITY OF THE LEAD.

    Additional Manufacturer Narrative · 1

    (B)(4).

    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). THE PRODUCT IS EXPECTED TO BE RETURNED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON RETURN AND COMPLETION OF ANALYSIS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV) LEAD DISLODGED INTO THE PATIENT'S CORONARY SINUS. IT WAS ALSO NOTED THAT LEAD EXHIBITED INCREASED PACING THRESHOLDS AND THE PATIENT EXPERIENCED PHRENIC NERVE STIMULATION WITH RV OUTPUT SET AT APPROXIMATELY 2.8 V. FOLLOWING IMPLANT OF A LEFT VENTRICULAR ASSIST DEVICE (LVAD) AND RECOVERY OF THE PATIENT'S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) FROM A FAULT CODE, IT WAS REPROGRAMMED TO MONITOR ONLY AS THE PATIENT HAD SUFFICIENT THERAPY FROM THE LVAD. A PROCEDURE TO REVISE THE POSITION OF THE RV LEAD WILL TAKE PLACE IN THE FUTURE FOLLOWING THE PATIENT'S RECOVERY FROM LVAD IMPLANT. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE LEAD AND ICD REMAIN IMPLANTED BUT NOT IN SERVICE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED INDICATING THE PLANNED REVISION PROCEDURE WAS PERFORMED AND THIS RV LEAD WAS EXPLANTED AND REPLACED. AT THE TIME OF REVISION,A FRACTURE OF THE LEAD'S DISTAL COIL WAS FOUND AND BELIEVED TO BE THE POSSIBLE RESULT OF LVAD IMPLANT. PRIOR TO THE REVISION ABNORMAL IMPEDANCE MEASUREMENTS AND A SLIGHTLY INCREASED SHOCK IMPEDANCE OF 62 OHMS WERE OBSERVED IN ADDITION TO ALTERNATING R-WAVE SIGNAL AMPLITUDES. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    383332 ENDOTAK RELIANCE NVY CPI - DEL CARIBE 0296

    Patients

    Seq Age Sex Outcome Treatment
    1