BEUDAMED
    FDA Adverse Event Death Summary report: N

    PROTECTA VR

    MDR report key: 3856332 · Received June 9, 2014

    Report

    Report Number
    9614453-2014-01070
    Event Type
    Death
    Date Received
    June 9, 2014
    Date of Event
    November 2, 2013
    Report Date
    September 28, 2015
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    LWS
    PMA / PMN Number
    P980016
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED AND ANALYZED. ANALYSIS WAS PERFORMED AND NO ANOMALIES WERE FOUND.

    Additional Manufacturer Narrative · 1

    THIS MODEL NUMBER IS NOT APPROVED FOR DISTRIBUTION IN THE UNITED STATES; HOWEVER, IT IS SAME/SIMILAR TO A DEVICE MARKETED IN THE U.S. THIS EVENT OCCURRED OUTSIDE THE US AND PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. (B)(4).

    Additional Manufacturer Narrative · 1

    THIS ADDITIONAL INFORMATION IS BASED ENTIRELY ON JOURNAL LITERATURE. THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS LIMITED DUE TO CONFIDENTIALITY CONCERNS. REFERENCED ARTICLE: STEPHEN TUOHY M.D., PAUL RYAN B.SC., JOSEPH GALVIN M.D., "TURNING A BLIND EYE TO THE FAR FIELD; ARE WE BURYING THE EVIDENCE? A CASE OF ABRUPT CATASTROPHIC ICD LEAD FAILURE CAUSING SUDDEN DEATH. " HEART RHYTHM CASE REPORTS, HTTP://DX.DOI.ORG/10.1016/J.HRCR.2015.07.004. THIS IS FROM THE JOURNAL: "THIS IS A PDF FILE OF AN UNEDITED MANUSCRIPT THAT HAS BEEN ACCEPTED FOR PUBLICATION. AS A SERVICE TO OUR CUSTOMERS WE ARE PROVIDING THIS EARLY VERSION OF THE MANUSCRIPT. THE MANUSCRIPT WILL UNDERGO COPYEDITING, TYPESETTING, AND REVIEW OF THE RESULTING GALLEY PROOF BEFORE IT IS PUBLISHED IN ITS FINAL CITABLE FORM. PLEASE NOTE THAT DURING THE PRODUCTION PROCESS ERRORS MAY BE DISCOVERED WHICH COULD AFFECT THE CONTENT, AND ALL LEGAL DISCLAIMERS THAT APPLY TO THE JOURNAL PERTAIN." (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS RECEIVED AND ANALYZED. ANALYSIS OF THE DEVICE MEMORY INDICATED THE UNEXPECTED DELIVERY OF A VENTRICULAR TACHYARRYTHMIA THERAPY, IT WAS NOTED THE LEAD NOISE ALGORITHM WITHHELD FOR EPISODES AND EVENTUALLY TIMED-OUT LEADING TO DETECTION FOR LEAD NOISE OVERSENSING AND VENTRICULAR FIBRILLATION (VF) THERAPY. SUBSEQUENT SHOCKS INDUCED VF WITHOUT TERMINATION.

    Additional Manufacturer Narrative · 1

    CORRECTED INFORMATION: NO EVAL EXPLAIN CODE.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT IS DECEASED. IT WAS FURTHER REPORTED THAT LEAD NOISE WAS PRESENT. A LEAD INTEGRITY ALERT (LIA) WAS TRIGGERED AND THE LEAD NOISE DISCRIMINATION ALGORITHM WAS ACTIVATED AND WITHHELD THERAPY DUE TO NOISE. THE ALGORITHM TIMEOUT EXPIRED AFTER DEFAULT SETTING OF FORTY-FIVE SECONDS HAD PASSED AND THE DEVICE DELIVERED THERAPY. AFTER THE FOURTH - THIRTY-FIVE JOULE SHOCK, VENTRICULAR FIBRILLATION (VF) WAS INITIATED AND THE SUBSEQUENT SHOCKS WERE UNABLE TO BREAK THE ARRHYTHMIA. THE PATIENT DIED IMMEDIATELY FOLLOWING THIS EVENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED IN THE FORM OF A PRE-PUBLICATION SCIENTIFIC JOURNAL ARTICLE. THE ARTICLE REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD HAD AN "ABRUPT" RISE IN THE PACE-SENSE IMPEDANCE. THERE WAS AN APPARENT FRACTURE. THE ALGORITHM IN PLACE DID NOT FUNCTION PROPERLY AND THE PATIENT EXPERIENCED "INDUCED VENTRICULAR FIBRILLATION (VF)."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335895 PROTECTA VR DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS IPG MFG SWITZERLAND D364VRG

    Patients

    Seq Age Sex Outcome Treatment
    1 00029 YR Death