BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE S

    MDR report key: 2791736 · Received October 15, 2012

    Report

    Report Number
    2649622-2012-15464
    Event Type
    Injury
    Date Received
    October 15, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S039
    Removal / Correction Number
    Z-0474-2011
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. EVALUATION SUMMARY: (B)(4) - THE PARTIAL LEAD WAS RETURNED IN SEGMENTS, ANALYZED AND THE PROXIMAL CONDUCTOR WAS FRACTURED. IT WAS NOTED THAT THE DEFIBRILLATION COIL WAS DISTORTED, THERE WAS BLOOD/BODY FLUID ON THE OUTER TUBING OVERLAY, THE OUTER TUBING OVERLAY MELTED, THE OUTER TUBING OVERLAY COSMETIC ENVIRONMENTAL STRESS CRACKING, THE OUTER INSULATION HAD A COSMETIC DEPRESSION, THERE WAS BLOOD IN/ON THE HELIX/LOBE MECHANISM (SLEEVE HEAD), THERE WAS BLOOD IN/ON THE HELIX/LOBE MECHANISM AND THERE WAS TISSUE ON THE HELIX.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS AN AUDIBLE PATIENT ALERT FOR HIGH PACING LEAD IMPEDANCE (>3000 OHM), OVERSENSING AND HIGH THRESHOLDS ON THE RIGHT VENTRICULAR LEAD. THE LEAD WAS EXTRACTED 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
    1 SPRINT QUATTRO SECURE S IMPLANTABLE TACHY LEAD LWS MEDTRONIC PUERTO RICO, INC. 6935

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Hospitalization| R D144DRG IMPLANTABLE PACEMAKER/CARDIO/DEFIB| D144DRG IMPLANTABLE PACEMAKER/CARDIO/DEFIB