BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT

    MDR report key: 3276863 · Received August 9, 2013

    Report

    Report Number
    2649622-2013-08863
    Event Type
    Injury
    Date Received
    August 9, 2013
    Report Date
    February 13, 2024
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BASED SOLELY ON DEVICE ANALYSIS. NO INFORMATION TO SUGGEST A DEVICE RELATED ADVERSE EVENT OR PRODUCT PROBLEM WAS RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PRODUCT EVENT SUMMARY: THE FULL LEAD WAS RETURNED IN SEGMENTS. ANALYSIS INDICATED THAT THE OUTER INSULATION OF THE LEAD DEVELOPED A BREACH DUE TO A DEPRESSION WHILE IN VIVO. CONTINUATION: D224TRK IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD)  2009-(B)(6), 5076-45 IMPLANTABLE PACING LEAD 2002-(B)(6), 4193 IMPLANTABLE PACING LEAD 2005-03-31. (B)(4).

    Description of Event or Problem · 1

    THE RIGHT VENTRICULAR LEAD WAS RETURNED TO THE MANUFACTURER, ANALYZED AND 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
    380247 SPRINT DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 694365V

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Female Hospitalization| R