BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE S

    MDR report key: 3992630 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-09772
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    June 24, 2014
    Report Date
    June 25, 2014
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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. PRODUCTS: 5076-52 LEAD IMPLANTED: (B)(6) 2006. (B)(4).

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE PROXIMAL CONDUCTOR OF THE LEAD DEVELOPED A FRACTURE DUE TO FLEXING WHILE IN VIVO; FULL LEAD IN SEGMENTS RETURNED AND ANALYZED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT LIA (LEAD INTEGRITY ALERT) TRIGGERED, WITH ONE NST (NON-SUSTAINED TACHYCARDIA) EPISODE WITH NOISE, AND A NUMBER OF OTHER EPISODES DUE TO AF (ATRIAL FIBRILLATION) WITH RVR (RAPID VENTRICULAR RESPONSE). PACING IMPEDANCE HAD ALSO JUMPED TO HIGH LEVELS. A HIGH NUMBER OF V-V INTERVALS, NO CAPTURE, AND A CONFIRMED LEAD FRACTURE WERE ALSO REPORTED. THE DEVICE AND LEAD WERE EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    469028 SPRINT QUATTRO SECURE S DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 693565

    Patients

    Seq Age Sex Outcome Treatment
    1 00078 YR Hospitalization| R (B)(4) ICD