BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE S

    MDR report key: 3864661 · Received June 10, 2014

    Report

    Report Number
    2649622-2014-07404
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    April 4, 2014
    Report Date
    April 4, 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
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE PARTIAL LEAD WAS RETURNED IN SEGMENTS AND ANALYZED. THE PROXIMAL CONDUCTOR OF THE LEAD DEVELOPED A FRACTURE DUE TO FLEXING WHILE IN VIVO. ANALYSIS INFORMATION -- (B)(6) 2014, 13:23:36 CST, (B)(4), PRODUCT ID# D284DRG. THE DEVICE WAS RETURNED AND ANALYZED. NO ANOMALIES WERE FOUND AND THERE WERE NO ISSUES. NO ISSUE WAS IDENTIFIED THAT REQUIRED FULL ANALYSIS. THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CONCOMITANT MEDICAL PRODUCTS: D284DRG, IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD), (B)(6) 2013. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD DELIVERED EIGHT INAPPROPRIATE SHOCKS TO THE PATIENT. THE LEAD EXHIBITED OVERSENSING DUE TO NOISE AND A HIGH NUMBER OF SHORT INTERVAL COUNTS (SIC). ADDITIONALLY, A LEAD FRACTURE IS SUSPECTED. THE LEAD HAS BEEN EXPLANTED, REPLACED AND RETURNED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340786 SPRINT QUATTRO SECURE S DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 693558

    Patients

    Seq Age Sex Outcome Treatment
    1 00050 YR Hospitalization| L| R 5076 IMPLANTABLE PACING LEAD