BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TBD

    MDR report key: 3153536 · Received June 8, 2013

    Report

    Report Number
    2649622-2013-06076
    Event Type
    Malfunction
    Date Received
    June 8, 2013
    Report Date
    March 15, 2013
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P850089
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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. CONCOMITANT PRODUCTS: PRODUCT ID 5024M IMPLANTABLE PACING LEAD (B)(6) 1994; 284-05 COMPETITOR IMPLANTABLE PULSE GENERATOR (IPG) (B)(6) 1994. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S RIGHT ATRIAL (RA) LEAD AND RIGHT VENTRICULAR (RV) LEADS BOTH SHOWED NOISE ON THE ELECTROGRAM ALONG WITH MIRROR LIKE IMAGES. THERE WAS ALSO NOTED A SLIGHT INCREASE IN THRESHOLDS. BOTH LEADS REMAIN IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    257772 TBD ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5524M-53

    Patients

    Seq Age Sex Outcome Treatment
    1