BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO

    MDR report key: 2964637 · Received February 15, 2013

    Report

    Report Number
    2649622-2013-01945
    Event Type
    Injury
    Date Received
    February 15, 2013
    Report Date
    December 21, 2012
    Manufacturer
    MPRI
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BASED SOLELY ON DEVICE RETURN AND ANALYSIS. NO INFORMATION SUGGESTS A DEVICE-RELATED ADVERSE EVENT OR PRODUCT PROBLEM WAS RECEIVED. THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PRODUCT EVALUATION SUMMARY: THE FULL LEAD IN SEGMENTS WAS RETURNED, ANALYZED AND THE DISTAL CONDUCTOR WAS FRACTURED FROM STRESS. IT WAS NOTED THAT THE DISTAL END LOW VOLTAGE ELECTRODE WAS COVERED WITH BODY TISSUE/FIBROTIC GROWTH AND BLOOD AND THE OUTER TUBING OVERLAY HAD COSMETIC ENVIRONMENTAL STRESS CRACKING, ALSO THE EXPOSED SUPERIOR VENA CAVA (SVC) COIL WAS DISTORTED FROM BEING PULLED/STRETCHED/OVERSTRESSED, WAS KINKED/BUCKLED AND FRACTURED FROM BEING PULLED/STRETCHED/OVERSTRESSED. (B)(4).

    Description of Event or Problem · 1

    THE RIGHT VENTRICULAR (RV) LEAD WAS RETURNED TO THE MANUFACTURER WITH NO INFORMATION AFTER BEING EXPLANTED AND REPLACED. THE LEAD WAS ANALYZED AND TESTED OUT OF SPECIFICATION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    FOLLOW UP WITH THE CLINIC DETERMINED THE PATIENT HAD PRESENTED TO THE CLINIC DUE TO A PATIENT ALERT SOUNDING. THERE WERE MULTIPLE EPISODES OF OVERSENSING, EVIDENCE OF AN RV LEAD FRACTURE, HIGH IMPEDANCE AND NOISE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    67305 SPRINT QUATTRO DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 6947

    Patients

    Seq Age Sex Outcome Treatment
    1 00068 YR Hospitalization| R 7232CX IMPLANTABLE CARDIOVERTER DEFIBRILLATOR