BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 4163321 · Received October 10, 2014

    Report

    Report Number
    2649622-2014-12385
    Event Type
    Injury
    Date Received
    October 10, 2014
    Date of Event
    July 10, 2014
    Report Date
    July 10, 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
    JA
    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. PRODUCT EVENT SUMMARY: THE PROXIMAL SEGMENT OF THE LEAD WAS RETURNED, ANALYZED AND ANALYSIS WAS PERFORMED AND NO ANOMALIES WERE FOUND. THERE WAS BLOOD ON THE DISTAL CONDUCTOR OF THE LEAD AND IT WAS NOT OBSTRUCTED. AN EXTRINSIC BREACH/CUT WAS NOT OBSERVED ON THE PROXIMAL SEGMENT THAT WAS RETURNED. THIS DEVICE WAS INCLUDED IN THAT FIELD ACTION, BUT RETURNED PRODUCT TESTING FOUND THE DEVICE DID PERFORM AS DESCRIBED IN THE FIELD ACTION.  (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT LOST CONSCIOUSNESS DUE TO VENTRICULAR FIBRILLATION (VF) AND THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DELIVERED A DEFIBRILLATION SHOCK(S). A DEVICE CHECK WAS PERFORMED BY THE MEDICAL ENGINEER AT THE HOSPITAL, AND DEVICE RESET STATUS WAS CONFIRMED. THE DEVICE WAS EXPLANTED AND REPLACED. DURING THE DEVICE REPLACEMENT, BLOOD INFLOW WAS CONFIRMED WHEN THE IS-1 PIN OF THE CUT RIGHT VENTRICULAR (RV) LEAD WAS CHECKED. A NEW RV LEAD WAS IMPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    644724 SPRINT QUATTRO SECURE DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 694765

    Patients

    Seq Age Sex Outcome Treatment
    1 00082 YR Hospitalization| L| R D234VRC ICD