BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 2791543 · Received October 15, 2012

    Report

    Report Number
    2649622-2012-15448
    Event Type
    Injury
    Date Received
    October 15, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S24
    Removal / Correction Number
    Z-0475-2011
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 FULL LEAD WAS RETURNED IN SEGMENTS AND ANALYZED. THE PROXIMAL CONDUCTOR WAS FRACTURED. THE OUTER TUBING OVERLAY HAD BLOOD/BODY FLUID, WAS MELTED, AND HAD COSMETIC ENVIRONMENTAL STRESS CRACKING. THE OUTER INSULATION HAD COSMETIC DEPRESSION. THE HELIX/LOBE WAS DISTORTED/BENT. THERE WAS BLOOD IN/ON THE HELIX/LOBE MECHANISM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR LEAD WAS FRACTURED. THE LEAD WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS WERE NOTED 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

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization| R (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 5076 IMPLANTABLE PACING LEAD