BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 1921452 · Received December 13, 2010

    Report

    Report Number
    2649622-2010-12532
    Event Type
    Injury
    Date Received
    December 13, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S24
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION SUMMARY: (B)(4): THE PARTIAL LEAD WAS RETURNED IN FRAGMENTS AND ANALYZED. ANALYSIS RESULTS REVEALED THE DISTAL CONDUCTOR WAS FRACTURED. BLOOD/BODY FLUID WAS PRESENT ON SEVERAL CONDUCTORS (NOT OBSTRUCTED), ON THE OUTER TUBING OVERLAY, AND IN/ON THE HELIX MECHANISM AND SLEEVE HEAD. IT WAS ALSO OBSERVED THAT THE DEFIB CONDUCTOR WAS DISTORTED, THE DISTAL CONDUCTOR WAS CUT, THE OUTER TUBING WAS KINKED/BUCKLED AND TORN. THERE WAS A WHITE SUBSTANCE ON THE EXPOSED DEFIB COIL. COSMETIC ENVIRONMENTAL STRESS CRACKS WERE PRESENT ON THE OUTER INSULATION, AND THERE WAS A COSMETIC OUTER INSULATION DEPRESSION.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. ANALYSIS OF THE DEVICE IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VENTRICULAR LEAD HAD DECREASED IMPEDANCE, DIMINISHING R-WAVES AND A SUSPECTED FAILURE. THE LEAD WAS REMOVED, REPLACED AND RETURNED. 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 IMPLANTABLE TACHY LEAD LWS MEDTRONIC PUERTO RICO, INC. 6947 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| R 7231CX IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 7231CX IMPLANTABLE PACEMAKER/CARDIO/DEFIB