BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT QUATTRO SECURE S

    MDR report key: 3992950 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-09586
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Date of Event
    May 11, 2014
    Report Date
    May 12, 2014
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY UPDATE: ANALYSIS OF THE DEVICE MEMORY INDICATED RV (RIGHT VENTRICULAR) OVERSENSING.

    Additional Manufacturer Narrative · 1

    CORRECTED INFORMATION: NO EVAL EXPLAIN CODE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CONCOMITANT: DTBA1D1 ICD IMPLANTED: 2013-(B)(6), 1388TC-46 ST. JUDE LEAD IMPLANTED: 2005-(B)(6), (B)(4).

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: ANALYSIS OF THE DEVICE MEMORY WAS PERFORMED AND NO ANOMALIES WERE FOUND.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE PATIENT WAS ADMITTED FOR RETURNED SYMPTOMS DUE TO TWOS WITH REDUCED PACING RATE. MULTIPLE PROGRAMMING MEASURES WERE ATTEMPTED TO AVOID TWOS, AND THE RV LEAD HAD APPARENTLY BEEN REPOSITIONED ONCE OR TWICE IN THE PAST.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE OR COMPLAINING OF PRE-SYNCOPAL SYMPTOMS. THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED T-WAVE OVERSENSING (TWOS) WITH ALL SENSING CONFIGURATIONS AND ESPECIALLY WITH LOWER OUTPUT RV PACING. THE PATIENT HAS HAD SOME CHRONIC TWOS. THE LEAD REMAINS 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
    472311 SPRINT QUATTRO SECURE S DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 693565

    Patients

    Seq Age Sex Outcome Treatment
    1 00028 YR Hospitalization| R 429688 LEAD