BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE S

    MDR report key: 4832569 · Received June 10, 2015

    Report

    Report Number
    2649622-2015-07490
    Event Type
    Injury
    Date Received
    June 10, 2015
    Date of Event
    April 7, 2015
    Report Date
    April 8, 2015
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE FULL LEAD WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND, THE DISTAL LV (LOW VOLTAGE) ELECTRODE OF THE LEAD WAS COVERED IN BLOOD, AND THE HELIX OF THE LEAD WAS EXTRINSICALLY BENT. VISUAL SUMMARY ANALYSIS OF THE LEAD INDICATED APPARENT EXPLANT DAMAGE. ANALYST COMMENTED, THE LEAD WAS RETURNED WITH THE HELIX BENT. THE LEAD WAS RETURNED WITH DRIED BLOOD ON THE HELIX AND WITHIN THE SLEEVEHEAD.

    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).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE PATIENT WAS SEEN FOR SYSTEM CHECK, RIGHT VENTRICULAR (RV) LEAD PERFORATION OF THE RIGHT VENTRICULAR APEX WAS IDENTIFIED. THE PATIENT WAS HOSPITALIZED AND TESTS PERFORMED. CHEST XRAY CONFIRMED RV LEAD POSITION WAS SIMILAR TO THE POSITION POST IMPLANT. THERE WAS NO EVIDENCE OF TAMPONADE DURING ECHOCARDIOGRAPHY. REPEATED CHEST XRAYS SHOWED LUNG VOLUMES DIMINISHED COMPARED TO 2 DAYS PRIOR. THE RV LEAD WERE REMOVED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. THE PATIENT IS A PARTICIPANT IN THE REFINE ICD POST-MARKET STUDY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    380533 SPRINT QUATTRO SECURE S DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 6935M62

    Patients

    Seq Age Sex Outcome Treatment
    1 00066 YR Hospitalization| L| R DVBB2D4 ICD