BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT

    MDR report key: 4161797 · Received October 10, 2014

    Report

    Report Number
    2649622-2014-11410
    Event Type
    Malfunction
    Date Received
    October 10, 2014
    Date of Event
    August 5, 2014
    Report Date
    August 5, 2014
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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 OVERSENSING ASSOCIATED WITH THE RIGHT VENTRICULAR LEAD THE ANALYST NOTED THE FOLLOWING: BEGINNING (B)(6) 2014, SENSING INTEGRITY COUNTS UP TO 1790; NST EPISODES COLLECTED WITH R-WAVE DOUBLE COUNTING AS SHORT INTERVALS; RV LEAD INTEGRITY WARNING OCCURRED (B)(6) 2014 FOR SENSING INTEGRITY COUNTER GREATER THAN 30 IN 3 DAYS AND VT-NS EPISODES.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A LEAD INTEGRITY ALERT (LIA) WAS TRIGGERED DUE TO DOUBLE COUNTING OF VENTRICULAR TACHYCARDIA (VT) BY THE RIGHT VENTRICULAR (RV) LEAD DURING SOME NON-SUSTAINED TACHYCARDIA EPISODES. IT WAS FURTHER REPORTED THAT THE RV LEAD DEMONSTRATED CONSISTENTLY HIGH SHORT INTERVAL COUNTS (SIC). THE PHYSICIAN ELECTED NOT TO ADJUST ANY PROGRAMMING AT THIS TIME, AND NO INTERVENTION WAS DONE. THE LEAD REMAINS IN USE AND NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    639781 SPRINT DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 6932-65

    Patients

    Seq Age Sex Outcome Treatment
    1 00063 YR D314VRG ICD