BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE S

    MDR report key: 2791634 · Received October 15, 2012

    Report

    Report Number
    2649622-2012-14850
    Event Type
    Injury
    Date Received
    October 15, 2012
    Date of Event
    August 13, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, 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 AND ANALYZED. BLOOD WAS OBSERVED IN/ON THE HELIX/LOBE MECHANISM. THE OUTER TUBING OVERLAY WAS MELTED. APPARENT EXPLANT DAMAGE WAS NOTED. (B)(4) THE FULL LEAD WAS RETURNED AND ANALYZED. BLOOD WAS OBSERVED IN/ON THE HELIX/LOBE MECHANISM. THE PROXIMAL CONDUCTOR WAS DISTORTED AND THE OUTER INSULATION WAS BREACHED/CUT. APPARENT EXPLANT DAMAGE WAS NOTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) AND RIGHT ATRIUM (RA) LEADS WERE NICKED BY THE CAUTERY DEVICE DURING A PROCEDURE. THE RV AND RA LEADS WERE EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS WERE 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 47 YR Hospitalization| R (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB