BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 1072506 · Received July 10, 2008

    Report

    Report Number
    2649622-2008-03711
    Event Type
    Injury
    Date Received
    July 10, 2008
    Date of Event
    April 16, 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
    OK, 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: PROXIMAL CONDUCTOR FRACTURED; PROXIMAL SEGMENT RETURNED AND ANALYZED. OTHER: IT WAS REPORTED THE LEAD WAS REPLACED DUE TO OVERSENSING, IMPEDANCE FLUCTUATIONS AND APPARENT FRACTURE THAT INVOLVED BOTH THE PACE/SENSE PORTION OF THE LEAD AND THE HV COILS OF THE LEAD. NO PATIENT COMPLICATIONS WERE 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, IMPEDANCE, HIGH, LEAD(S), FRACTURE OF, OVERSENSING.

    Description of Event or Problem · 1

    IT WAS REPORTED THE LEAD WAS REPLACED DUE TO OVERSENSING, IMPEDANCE FLUCTUATIONS AND APPARENT FRACTURE THAT INVOLVED BOTH THE PACE/SENSE PORTION OF THE LEAD AND THE HV COILS OF THE LEAD. 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 IMPLANTABLE TACHY LEAD LWS MEDTRONIC PUERTO RICO, INC. 6947 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention 5076 IMPLANTABLE PACING LEAD