BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 3994011 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-09010
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    June 3, 2014
    Report Date
    June 3, 2014
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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 PRODUCT : 5076-58 LEAD IMPLANTED (B)(6) 2008. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY : THE ACTUAL LEAD WAS NOT RECEIVED FOR EVALUATION, HOWEVER PERFORMANCE DATA WAS COLLECTED FROM THE DEVICE AND ANALYZED. ANALYSIS REVEALED NO ANOMALIES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR TACHY LEAD HAD LOW R WAVES AND T WAVE OVERSENSING WAS OCCURRING. THE PACE/SENSE PORTION OF THE LEAD WAS CAPPED AND REPLACED, AND THE HIGH VOLTAGE PORTION REMAINED IN USE. SUBSEQUENTLY, THE PACE/SENSE LEAD IMPEDANCE WAS NOTED TO HAVE STEADILY INCREASED SINCE IMPLANT TO 1100 OHMS, THE IMPEDANCE WAS HIGH AND A POSSIBLE FRACTURE WAS NOTED. THE PHYSICIAN USED THE LEAD ANALYZER TO CHECK THE SENSING ON THE TACHY LEAD, HOWEVER THE R WAVES WERE STILL LOW. BOTH LEADS WERE CAPPED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    471781 SPRINT QUATTRO SECURE DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 694765

    Patients

    Seq Age Sex Outcome Treatment
    1 00058 YR Hospitalization| R 7232CX ICD