BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO

    MDR report key: 2122192 · Received June 13, 2011

    Report

    Report Number
    2649622-2011-07837
    Event Type
    Injury
    Date Received
    June 13, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S17
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR LEAD HAD DECREASING AND THEN LOW PACING IMPEDANCE. DURING THE LEAD REVISION, THE PHYSICIAN NOTED THAT THE "SUTURES WERE DRAWN TIGHT ACROSS THE LEAD BODY, CUTTING INTO THE LEAD." THE LEAD WAS CAPPED AND REPLACED. IT WAS ADDITIONALLY REPORTED THAT THE VENTRICULAR LEAD PACE/SENSE PORTION WAS ABANDONED DUE TO DIFFICULTY SENSING R-WAVES. THE LEAD WAS CAPPED 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 IMPLANTABLE TACHY LEAD LWS MEDTRONIC PUERTO RICO, INC. 6944 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Hospitalization| R 7232CX IMPLANTABLE PACEMAKER/CARDIO/DEFIB