BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NONE

    MDR report key: 1071941 · Received July 10, 2008

    Report

    Report Number
    2649622-2008-03381
    Event Type
    Malfunction
    Date Received
    July 10, 2008
    Date of Event
    September 12, 2007
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    ASKU
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BASED SOLELY ON DEVICE RETURN AND ANALYSIS. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION SUMMARY: OUTER INSULATION BREACHED; PROXIMAL SEGMENT RETURNED. SUPPLEMENTAL REPORT CREATED WITH UPDATED CAUSAL CODE. ALERT DATE UPDATED TO THE CORRECT DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NONE IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 4058M ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Other 5024M IMPLANTABLE PACING LEAD| 4193 IMPLANTABLE PACING LEAD| 8042 IMPLANTABLE PULSE GENERATOR