BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT

    MDR report key: 4499080 · Received February 10, 2015

    Report

    Report Number
    2649622-2015-01633
    Event Type
    Injury
    Date Received
    February 10, 2015
    Date of Event
    September 1, 2014
    Report Date
    November 10, 2014
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    THIS INFORMATION IS BASED ON JOURNAL LITERATURE, THE PREVIOUSLY REPORTED INFORMATION, AND COMPANY REPRESENTATIVE FOLLOW UP. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS LIMITED DUE TO CONFIDENTIALITY CONCERNS. REFERENCED ARTICLE: WHITTAKER-AXON S, BREITENSTEIN A, FINLAY MMRCPPD. AN ISOLATED AND TRANSIENT LEAD IMPEDANCE ALERT AS THE SOLE INDICATOR OF ICD SYSTEM FAILURE. PACE PACING AND CLINICAL ELECTROPHYSIOLOGY. 2016;39(9):1022-1025.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    CORRECTED INFORMATION: SEX. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE LEAD WAS NOT RETURNED FOR ANALYSIS. HOWEVER, PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS RECEIVED AND ANALYZED. ANALYSIS OF THE DEVICE MEMORY INDICATED THE IMPEDANCE ON THE RV (RIGHT VENTRICULAR) DEFIBRILLATION COIL WAS BEYOND THE EXPECTED LOWER RANGE. ON (B)(6) 2014, RIGHT VENTRICULAR (RV) LEAD DEFIBRILLATION IMPEDANCE MEASURED 18 OHMS. (B)(4)

    Description of Event or Problem · 1

    IT WAS INITIALLY STATED THAT IT WAS REPORTED THE RIGHT VENTRICULAR (RV) LEAD HAD A SINGLE HIGH IMPEDANCE MEASUREMENT, BUT IT SHOULD HAVE STATED THAT THE RV LEAD HAD A SINGLE LOW IMPEDANCE MEASUREMENT. IT WAS ALSO NOTED THAT THE PATIENT HAD FATIGUE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD HAD A SINGLE HIGH IMPEDANCE MEASUREMENT. THE PATIENT CAME TO THE CLINIC AND ALL PARAMETERS "TESTED FINE." THE HOSPITAL STAFF DID A CARDIOVERSION WHICH CAUSED AN ELECTRICAL RESET TO THE DEVICE. WIRELESS TELEMETRY WAS LOST. THE STAFF REPEATED THE CARDIOVERSION AND ANOTHER ELECTRICAL RESET OCCURRED. THE DEVICE WAS EXPLANTED AND REPLACED. AFTER THE NEW DEVICE WAS IMPLANTED THE DEFIBRILLATION THRESHOLD FAILED. THE RV LEAD WAS REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED VIA A JOURNAL ARTICLE. THERE WAS MULTIPLE SHORT V-V INTERVALS/NOISE NOTED AND WERE INCREASING BY 50 INTERVALS EVERY SIX MONTHS; HOWEVER, THEY WERE NOT ENOUGH TO TRIGGER THE SENSING INTEGRITY COUNTER. TESTING WAS DONE IN THE CLINIC AND NO NOISE EPISODES WERE FOUND. THE LEAD WAS CAPPED AND "BURIED RATHER THAN EXTRACTED." WITH THE NEW LEAD, A "SUCCESSFUL DFT [DEFIBRILLATION THRESHOLDS TESTING] WAS PERFORMED." NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    96546 SPRINT DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 6932

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| R