BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SORIN PARADYM CRT 8750 150YHOB2 PULSE GENERATOR

    MDR report key: 13282565 · Received January 14, 2022

    Report

    Report Number
    MW5106692
    Event Type
    Malfunction
    Date Received
    January 14, 2022
    Date of Event
    August 26, 2021
    Report Date
    January 12, 2022
    Manufacturer
    SORIN CRM SAS
    Product Code
    DXY
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    HEADER SEPARATION OF PULSE GENERATOR WAS FOUND INTRAOPERATIVELY, FOR PLANNED RV LEAD REVISION. THE PRODUCT NAME IS "SORIN PARADYM CRT 8750 150YHOB2." FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    217192 SORIN PARADYM CRT 8750 150YHOB2 PULSE GENERATOR IMPLANTABLE PACEMAKER PULSE-GENERATOR DXY SORIN CRM SAS

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Male