BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3951194 · Received July 22, 2014

    Report

    Report Number
    2124215-2014-08352
    Event Type
    Injury
    Date Received
    July 22, 2014
    Date of Event
    April 6, 2014
    Report Date
    April 12, 2016
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT IN OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE PROXIMAL LEAD SEGMENT WAS PERFORMED. THE LEAD HAD BEEN SEVERED 115MM FROM THE TERMINAL PIN. RESISTANCE TESTING CONFIRMED THE ELECTRICAL CONTINUITY OF THE SEGMENT. NO FURTHER TESTING WAS PERFORMED. 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

    ADDITIONAL INFORMATION WAS RECEIVED NEARLY TWO YEARS FOLLOWING THE REPORTED CLINICAL OBSERVATIONS CONFIRMING THAT THIS PATIENT HAD PASSED AWAY DUE TO A NON-CARDIAC ISSUE. THIS LEAD WAS RETURNED FOR TESTING. THE PRODUCT ISSUE WILL BE UPDATED WHEN EVALUATION IS COMPLETE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) AND RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH, OUT-OF-RANGE SHOCK IMPEDANCE MEASUREMENTS DETECTED THROUGH THE REMOTE MONITORING SYSTEM. ADDITIONAL INFORMATION WAS RECEIVED FROM A LOCAL FIELD REPRESENTATIVE INDICATING THAT THE CLINIC HAS MADE MULTIPLE ATTEMPTS AT GETTING THE PATIENT TO COME INTO THE OFFICE FOR EVALUATION BUT WERE UNSUCCESSFUL. NO INTERVENTION WAS PERFORMED AT THIS TIME. THE DEVICE AND LEAD REMAIN IN SERVICE AT THIS TIME. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    --

    Description of Event or Problem · 1

    SUBSEQUENT INFORMATION RECEIVED INDICATED THAT THE SYSTEM CONTINUED TO EXHIBIT HIGH OUT-OF-RANGE SHOCK LEAD IMPEDANCE MEASUREMENTS. THE PATIENT WAS RECENTLY SEEN IN THE CLINIC WHERE ISOMETRICS WERE LIKELY PERFORMED TO ELICIT NOISE. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) REVIEWED THE DATA AND NOTED NOISE ON THE SHOCK CHANNEL IN STORED EPISODES. TS DISCUSSED THE POSSIBLE CAUSES AND PROVIDED FURTHER TROUBLESHOOTING MEASURES. A LOCAL FIELD REPRESENTATIVE WAS CONTACTED BUT WAS UNABLE TO PROVIDE FURTHER INFORMATION AT THIS TIME. THE SYSTEM REMAINS IN SERVICE. NO FURTHER INFORMATION WAS RECEIVED.

    Description of Event or Problem · 1

    SUBSEQUENT INFORMATION RECEIVED INDICATED THAT THE SYSTEM CONTINUED TO EXHIBIT HIGH SHOCKING LEAD IMPEDANCE MEASUREMENTS GREATER THAN 125 OHMS. ADDITIONALLY, IT WAS REPORTED THAT THE PATIENT RECEIVED INAPPROPRIATE SHOCK THERAPY FOR ATRIAL FIBRILLATION (AF) WITH RAPID VENTRICULAR RESPONSE (RVR). NO NOISE WAS ABLE TO BE RECREATED IN-CLINIC, HOWEVER, PRESENTING ELECTROGRAM (EGM) SHOWED SOME NOISE ON THE SHOCK CHANNEL. SUBSEQUENTLY, A LOW ENERGY COMMANDED SHOCK WAS PERFORMED WITH NORMAL RESULTS. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) DISCUSSED THE POSSIBLE CAUSES. FURTHER, A LOCAL FIELD REPRESENTATIVE REPORTED THAT THE PHYSICIAN HAS ELECTED TO REPROGRAM THE SHOCKING VECTOR. THE SYSTEM REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    428019 ENDOTAK RELIANCE IMPLANTABLE LEAD LWS CPI - DEL CARIBE 0148

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Life Threatening| R N141| 1861| 4542| H217| 4469| 4592| MISMATCH