BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NONE

    MDR report key: 2951531 · Received February 9, 2013

    Report

    Report Number
    2649622-2013-00116
    Event Type
    Injury
    Date Received
    February 9, 2013
    Date of Event
    October 6, 2012
    Report Date
    December 6, 2012
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    K940703
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA 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 AND ANALYZED. THE INNER INSULATION WAS BREACHED WITH METAL ION OXIDATION. THE PROXIMAL CONDUCTOR WAS KINKED/BUCKLED, PULLED/STRETCHED/OVERSTRESSED. THE DISTAL AND PROXIMAL CONDUCTORS WERE COVERED IN BLOOD (NOT OBSTRUCTED). THE DISTAL ELECTRODE WAS COVERED WITH BLOOD. THE HELIX FIXATION WAS OVER RETRACTED, THE OUTER INSULATION WAS BREACH CUT, MELTED AND TORN ALONG WITH ENVIRONMENTAL STRESS CRACKING. THERE WAS COSMETIC ENVIRONMENTAL STRESS CRACKING ON THE OUTER INSULATION AND THE OUTER INSULATION HAD COSMETIC METAL ION OXIDATION. CONCOMITANT PRODUCTS: 4024 IMPLANTABLE PACING LEAD (B)(6) 1995. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD WAS REMOVED DUE TO MEDICAL JUDGEMENT. THE RA LEAD WAS RETURNED TO THE MANUFACTURER, WAS 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
    57316 NONE ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 4558M

    Patients

    Seq Age Sex Outcome Treatment
    1 00044 YR Hospitalization| R (B)(4) IMPLANTABLE PULSE GENERATOR (IPG)