BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2082388 · Received May 9, 2011

    Report

    Report Number
    2124215-2011-08137
    Event Type
    Death
    Date Received
    May 9, 2011
    Date of Event
    April 18, 2011
    Report Date
    January 15, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT, A REVIEW OF THE DEVICE DATA WAS PERFORMED. ENGINEERS CONFIRMED NO FAULTS OR SYSTEM RESETS HAD BEEN RECORDED. THE DEVICE DIAGNOSTICS SHOWED THE DAILY RV PACING AND SHOCK IMPEDANCE MEASUREMENTS WERE STABLE AND WITHIN NORMAL RANGES. THE RV PACING IMPEDANCE WAS APPROXIMATELY 390 OHMS AND THE SHOCK IMPEDANCE WAS APPROXIMATELY 43 OHMS UNTIL THE DATE OF DEATH. AFTER THE DATE OF DEATH ((B)(6) 2011), THE RV PACING IMPEDANCE INCREASED TO APPROXIMATELY 1,000 OHMS AND THE SHOCK IMPEDANCE INCREASED TO APPROXIMATELY 200 OHMS; NORMAL OPERATION POST MORTEM DUE TO CHANGES THAT OCCUR WITHIN THE TISSUE. THE MEASURED IMPEDANCE VALUES FROM THE DELIVERED SHOCKS IN EPISODE 28, THE LAST STORED EPISODE WHERE SHOCK THERAPY HAD BEEN DELIVERED, WERE 34, 34, 34, 35, AND 35 OHMS; SIMILAR TO SHOCK IMPEDANCE MEASUREMENTS FROM PREVIOUSLY DELIVERED SHOCKS. MEMORY REVIEW CONFIRMED NORMAL OPERATION WITH NO EVIDENCE OF A DEVICE OR LEAD MALFUNCTION.

    Additional Manufacturer Narrative · 1

    INVESTIGATION OF THIS CASE REMAINS ONGOING. ONCE NEW INFORMATION IS RECEIVED A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE COMPLETELY EXTRACTED LEAD, WAS PERFORMED. SETSCREW MARKS WERE NOTED ON THE TERMINAL PIN AND IN THE PROPER LOCATIONS. EVIDENCE OF INSULATION DAMAGE WAS OBSERVED; HOWEVER, SUGGESTIVE OF INDUCED DAMAGE WHICH LIKELY OCCURRED DURING THE EXPLANT PROCEDURE. THE HELIX WAS RETURNED PARTIALLY EXTENDED WITH BLOOD/BODY FLUID OBSERVED IN THE HELIX HOUSING. RESISTANCE TESTS WERE COMPLETED TO ASSESS LEADS ELECTRICAL PERFORMANCE AND INTEGRITY. MEASUREMENTS THROUGHOUT THESE TESTS WERE WITHIN NORMAL LIMITS. LABORATORY ANALYSIS DID NOT IDENTIFY ANY LEAD CHARACTERISTICS THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED CLINICAL OBSERVATIONS AS ONLY INDUCED DAMAGES WERE OBSERVED.

    Description of Event or Problem · 1

    SUBSEQUENTLY, APPROXIMATELY 1.5 YEARS POST-MORTEM, THIS LEAD WAS RECEIVED FOR DISPOSAL. THE RETURNED PRODUCT WAS SUBJECTED TO STANDARD POST-MARKET ANALYSIS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS DEVICE DELIVERED MULTIPLE SHOCKS AND SUBSEQUENTLY THE PATIENT EXPIRED. INTERROGATION OF THE DEVICE CONFIRMED MULTIPLE SHOCKING ATTEMPTS AS WELL AS A FAULT CODE INFORMING THE USER TO CHECK THE SHOCKING LEAD. DAILY MEASUREMENT TRENDING, DEMONSTRATED THAT THE SHOCK IMPEDANCE HAD SUDDENLY INCREASED FROM A STEADY NORMAL RANGE TO GREATER THAN 125 OHMS WITH NO DATE STAMP PROVIDED BY THE DEVICE INDICATING THE DATE OF THE FIRST HIGH SHOCKING IMPEDANCE WITH NO OTHER ABNORMAL MEASUREMENTS RECORDED. REVIEW OF DETAIL FOR EACH EVENT WITH SHOCK THERAPY, DEMONSTRATED ALL SHOCK IMPEDANCES WITHIN NORMAL RANGE (APPROX. 33 OHMS). ADDITIONALLY, WITH EACH SHOCK DELIVERED, THE ARRHYTHMIA WAS INITIALLY TERMINATED, HOWEVER, WITHIN SECONDS VT OR VF, ENSUED. A TOTAL OF 26 SHOCKS WERE DELIVERED - ALL EXCEPT ONE AT MAXIMUM ENERGY (14J, 41J). IT APPEARED THAT THE PATIENT MAY HAVE RECEIVED EXTERNAL SHOCKS BY PARAMEDICS; HOWEVER, THIS WAS NOT RECORDED IN ANY EXTERNAL DOCUMENTATION FILES. BOSTON SCIENTIFIC HAS REQUESTED PRODUCT RETURN FOR A TECHNICAL ASSESSMENT OF PERFORMANCE; HOWEVER, INFORMATION RECEIVED INDICATES THE DEVICE MAY BE DETAINED WITH THE CORONER FOR UP TO ONE CALENDAR YEAR. DEVICE DATA FILES TO BE SENT ELECTRONICALLY IN THE NEAR FUTURE AND THE ASSOCIATED RIGHT VENTRICULAR LEAD REMAINED IMPLANTED POST MORTEM.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Death