BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRAFLEX

    MDR report key: 3993381 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-09334
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    March 25, 2014
    Report Date
    March 31, 2014
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    K812599
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY- THE PROXIMAL SEGMENT OF THE LEAD WAS RETURNED, ANALYZED AND THE DISTAL CONDUCTOR OF THE LEAD DEVELOPED A FRACTURE DUE TO FLEXING WHILE IN VIVO. THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CONCOMITANT PRODUCT: 4951-35 LEAD (B)(6) 1992. (B)(4).

    Description of Event or Problem · 1

    THE LEAD WAS RETURNED TO THE MANUFACTURER AFTER BEING EXPLANTED DUE TO NO ALLEGED PRODUCT ISSUE. THE LEAD WAS ANALYZED AND TESTED OUT OF SPECIFICATION. FOLLOW-UP TO THE REPRESENTATIVE INDICATED NO NEW INFORMATION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    469921 SPECTRAFLEX ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 4951-35

    Patients

    Seq Age Sex Outcome Treatment
    1 00031 YR Hospitalization| R 8342 IPG