BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRANSVENOUS LEAD

    MDR report key: 3051505 · Received April 10, 2013

    Report

    Report Number
    2649622-2013-04883
    Event Type
    Injury
    Date Received
    April 10, 2013
    Report Date
    November 13, 2013
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    K883743
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    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: (B)(4) - THE PROXIMAL SEGMENT OF THE LEAD WAS RETURNED, ANALYZED AND ANALYSIS REVEALED ENVIRONMENTAL STRESS CRACKING BREACH OF THE OUTER INSULATION. IT WAS NOTED THE OUTER INSULATION WAS BREACHED CUT, THERE WAS BLOOD ON THE DISTAL AND PROXIMAL CONDUCTORS, THERE WAS A COSMETIC DEPRESSION AND COSMETIC ENVIRONMENTAL STRESS CRACKING OF THE OUTER INSULATION. PRODUCT: D314TRG IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD), IMPLANTED: (B)(6) 2012; 694365V IMPLANTABLE TACHY LEAD, IMPLANTED: (B)(6) 2004; 419388, IMPLANTED: (B)(6) 2004. (B)(4).

    Additional Manufacturer Narrative · 1

    FURTHER REVIEW PROMPTED A CHANGE IN THE DEVICE ANALYSIS RESULTS.

    Description of Event or Problem · 1

    THE 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
    154091 TRANSVENOUS LEAD ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 4058M45

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R