BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 4161730 · Received October 10, 2014

    Report

    Report Number
    2649622-2014-11439
    Event Type
    Injury
    Date Received
    October 10, 2014
    Date of Event
    August 14, 2014
    Report Date
    August 14, 2014
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Removal / Correction Number
    Z-0475-2011
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. (B)(4).

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE PROXIMAL SEGMENT OF THE LEAD WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND. THERE WAS BLOOD ON THE DISTAL CONDUCTOR OF THE LEAD AND IT WAS NOT OBSTRUCTED. THE ANALYST NOTED THAT AN INSULATION BREACH WAS NOT OBSERVED DURING ANALYSIS. A TRACE AMOUNT OF BLOOD WAS OBSERVED ON THE DISTAL CONDUCTOR. NO OTHER ANOMALIES WERE OBSERVED ON THE RETURNED LEAD PROXIMAL SEGMENT. ALL ELECTRICAL TESTING WAS WITHIN SPECIFIED PARAMETERS. THE FULL LEAD WAS NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED LOW PACING IMPEDANCE AND LOW HIGH-VOLTAGE IMPEDANCE. IN ADDITION, IT WAS NOTED THAT THERE WAS FLUID IN THE POCKET AND DISCOLORATION UNDER THE LEAD INSULATION INDICATIVE OF COMPROMISED LEAD INSULATION. THE RV LEAD WAS PARTIALLY EXPLANTED, CAPPED AND REPLACED SUCCESSFULLY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    639120 SPRINT QUATTRO SECURE DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 694765

    Patients

    Seq Age Sex Outcome Treatment
    1 00072 YR Hospitalization| R C174AWK ICD