BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 1072876 · Received July 10, 2008

    Report

    Report Number
    2649622-2008-03640
    Event Type
    Injury
    Date Received
    July 10, 2008
    Date of Event
    May 9, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    ASKU
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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: OUTER INSULATION BREACHED (CLAVICLE-RIB CRUSH); PARTIAL LEAD RETURNED IN SEGMENTS AND ANALYZED. DEFIB CONDUCTOR FRACTURED. FULL LEAD IN SEGMENTS RETURNED AND ANALYZED. IT WAS REPORTED THE RV LEAD WAS EXPLANTED AND REPLACED DUE TO OVERSENSING. THE ATRIAL LEAD WAS EXPLANTED, RETURNED TO THE MANUFACTURER, ANALYZED, AND SUBSEQUENTLY TESTED OUT OF SPECIFICATION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED ELECTRICAL TESTS PERFORMED, MECHANICAL TESTS PERFORMED, VISUAL EXAMINATION COMPONENT/SUBASSEMBLY FAILURE LEAD CONDUCTOR DEVICE WAS OUT OF SPECIFICATION IN A MANNER THAT RELATES TO EVENT OVERSENSING.

    Description of Event or Problem · 1

    IT WAS REPORTED THE RV LEAD WAS EXPLANTED AND REPLACED DUE TO OVERSENSING. THE ATRIAL LEAD WAS EXPLANTED, RETURNED TO THE MANUFACTURER, ANALYZED, AND SUBSEQUENTLY TESTED OUT OF SPECIFICATION. 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 Other| R D154AWG IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 5076 IMPLANTABLE PACING LEAD