BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE S

    MDR report key: 2964782 · Received February 15, 2013

    Report

    Report Number
    2649622-2013-02010
    Event Type
    Injury
    Date Received
    February 15, 2013
    Report Date
    December 28, 2012
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY : THE FULL LEAD WAS RETURNED AND ANALYZED WITH NO ANOMALIES FOUND. THE DISTAL CONDUCTOR WAS DISTORTED DUE TO OVER-ROTATION AND THE RIGHT VENTRICULAR DEFIBRILLATION COIL WAS PULLED/STRETCHED/OVERSTRESSED. THERE WAS BLOOD AND BODY TISSUE/FIBROTIC GROWTH ON THE DISTAL ELECTRODE AND BLOOD ON THE DISTAL CONDUCTOR. THE OVERLAY TUBING WAS MELTED CAUSING AN INSULATION BREACH AND THERE WAS COSMETIC MELTING OF THE OUTER INSULATION AND OUTER TUBING. A COSMETIC DEPRESSION ON THE OUTER INSULATION WAS NOTED, BLOOD HAD INGRESSED INTO THE OVERLAY TUBING, AND THERE WAS APPARENT EXPLANT DAMAGE.

    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)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR LEAD WAS OVERSENSING T WAVES AND THERE WERE NON-SUSTAINED VENTRICULAR TACHYCARDIA EPISODES; A LEAD INTEGRITY ALERT WAS TRIGGERED. THE LEAD WAS EXPLANTED 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
    68284 SPRINT QUATTRO SECURE S DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 693558

    Patients

    Seq Age Sex Outcome Treatment
    1 00022 YR Hospitalization| R D164VWC IMPLANTABLE DEFIBRILLATOR