BEUDAMED
    FDA Adverse Event Other Summary report: N

    ELAPASSPJ52

    MDR report key: 22556314 · Received July 21, 2025

    Report

    Report Number
    MW5173024
    Event Type
    Other
    Date Received
    July 21, 2025
    Date of Event
    June 4, 2025
    Report Date
    August 8, 2025
    Manufacturer
    ELA MEDICAL/MICROPORT CRM USA INC.
    Product Code
    DTB
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED IN A PRE-PROCEDURE DIAGNOSIS DOCUMENT THAT THE PACEMAKER LEAD EXHIBITED A MALFUNCTION. THE SPECIFIC LEAD AND ANOMALY WERE NOT STATED. PATIENT CODE: 4582. DEVICE CODE: 2588. REFERENCE REPORT #MW5173025. "THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2)".

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED ON 08/08/2025 FOR A REPORT #MW5173024 TO CHANGE THE MANUFACTURER. IT WAS REPORTED IN A PRE-PROCEDURE DIAGNOSIS DOCUMENT THAT THE PACEMAKER LEAD EXHIBITED A MALFUNCTION. THE SPECIFIC LEAD AND ANOMALY WERE NOT STATED. PATIENT CODE: 4582. DEVICE CODE: 2588. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2). REFERENCE REPORT: #MW5173025.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    802990 ELAPASSPJ52 PERMANENT PACEMAKER ELECTRODE DTB ELA MEDICAL/MICROPORT CRM USA INC. ELAPASSPJ52

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown