BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE S

    MDR report key: 3153520 · Received June 8, 2013

    Report

    Report Number
    2649622-2013-06066
    Event Type
    Injury
    Date Received
    June 8, 2013
    Date of Event
    March 13, 2013
    Report Date
    March 21, 2013
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Removal / Correction Number
    Z-0474-2011
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE FULL LEAD WAS RETURNED, ANALYZED, AND THE OUTER INSULATION OF THE LEAD WAS BREACHED DUE TO BI/MULTI-LUMEN TUBING VOIDS WHILE IN VIVO.

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS RECEIVED AND ANALYZED. ANALYSIS OF THE DEVICE MEMORY INDICATED LEAD WARNING ALERTS WHICH OCCURRED ON (B)(6) 2013 (RV PACE) AND (B)(6) 2012, (SVC). THE DEVICE MEMORY INDICATED OVERSENSING DUE TO NON-PHYSIOLOGIC SIGNALS/SIC (SENSING INTEGRITY COUNTER). IT WAS FURTHER NOTED THAT THERE WAS (B)(4) SIC WHICH OCCURRED SINCE (B)(6) 2013 AND 37 NONSUSTAINED TACHYCARDIA (NST) EPISODES OF LESS THAN 220 MS V-V CYCLE WERE RECORDED BETWEEN (B)(6) 2013.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE U.S. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WERE FAST NON-SUSTAINED VENTRICULAR TACHYCARDIA EPISODES AND INCREASED SHORT INTERVAL COUNTS OBSERVED IN THE RIGHT VENTRICULAR LEAD. THE LEAD WAS EXPLANTED AND REPLACED WITH A NEW LEAD. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    256867 SPRINT QUATTRO SECURE S DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 693565

    Patients

    Seq Age Sex Outcome Treatment
    1 00056 YR Hospitalization| R 7232CX IMPLANTABLE CARDIOVERTER DEFIBRILLATOR