BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT

    MDR report key: 3990013 · Received August 7, 2014

    Report

    Report Number
    2649622-2014-08847
    Event Type
    Injury
    Date Received
    August 7, 2014
    Date of Event
    May 17, 2014
    Report Date
    May 17, 2014
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PRODUCTS: 4568-53 LEAD IMPLANTED: 1999 (B)(6); 419688 LEAD IMPLANTED: (B)(6) 2011. (B)(4).

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: ANALYSIS OF THE DEVICE MEMORY INDICATED OVERSENSING DUE TO NON-PHYSIOLOGIC SIGNALS/SIC (SENSING INTEGRITY COUNTER), AND THAT THE CRITERIA FOR THE RIGHT VENTRICULAR LEAD INTEGRITY ALERT WERE MET.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT RECEIVED FOUR SHOCKS, AND THAT LIA (LEAD INTEGRITY ALERT) TRIGGERED DUE TO SHORT V-V INTERVALS CAUSING ELEVATED SIC (SENSING INTEGRITY COUNTER) AND NST (NON-SUSTAINED TACHYCARDIA) EPISODES. SEVERAL EPISODES OF SLOW VT (VENTRICULAR TACHYCARDIA) WERE NOTED, WHICH WERE EXTERNALLY SHOCKED IN THE EMERGENCY ROOM. THE PHYSICIAN THOUGHT THAT THERE MAY HAVE BEEN SOME FFRW (FAR-FIELD R-WAVE) OVERSENSING AS WELL, AND THAT SIMILAR "NOISE" WAS PRESENT AT THE IMPLANT OF THE DEVICE AT TIME OF INDUCTION. IT WAS ALSO REPORTED THAT THE DEVICE EXPERIENCED REDUCED SERVICE LIFE, DUE TO ELEVATED OUTPUTS AND HIGH PERCENTAGE PACING IN BOTH ATRIUM AND VENTRICLE. THE DEVICE WAS EXPLANTED AND REPLACED, AND THE LEADS REMAIN IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    465087 SPRINT DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 6942

    Patients

    Seq Age Sex Outcome Treatment
    1 00067 YR Hospitalization| L| R (B)(4) CRT-D