BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE S

    MDR report key: 2791401 · Received October 15, 2012

    Report

    Report Number
    2649622-2012-14225
    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 Location
    OH, 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 PROXIMAL SEGMENT OF THE LEAD WAS RETURNED, ANALYZED, AND NO ANOMALIES WERE FOUND. IT WAS NOTED THAT THE DEFIBRILLATION CONDUCTOR WAS DISTORTED, THERE WAS BLOOD/BODY FLUID ON ALL CONDUCTORS (NOT OBSTRUCTED), THE OUTER TUBING OVERLAY HAD COSMETIC ENVIRONMENTAL STRESS CRACKING, THE OUTER INSULATION WAS BREACHED CUT, THERE WAS BLOOD IN/ON THE HELIX/LOBE MECHANISM, TISSUE ON HELIX AND THERE WAS APPARENT EXPLANT DAMAGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR LEAD WAS SUSPECT OF FRACTURE, HAD NO CAPTURE, AND HAD A SUDDEN RISE IN IMPEDANCE. 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
    1 SPRINT QUATTRO SECURE S IMPLANTABLE TACHY LEAD LWS MEDTRONIC PUERTO RICO, INC. 6935

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| R D284VRC IMPLANTABLE PACEMAKER/CARDIO/DEFIB