BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SONTRTIP

    MDR report key: 19114842 · Received April 15, 2024

    Report

    Report Number
    MW5153853
    Event Type
    Injury
    Date Received
    April 15, 2024
    Date of Event
    March 15, 2024
    Report Date
    April 11, 2024
    Manufacturer
    SORIN CRM SAS
    Product Code
    LWS
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    A HOSPITAL IMPLANT REGISTRATION FORM RECEIVED BY THE COMPANY ON 2024-04-02 INDICATED THAT ON (B)(6) 2024, THE PATIENT'S ENTIRE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM, INCLUDING AN (B)(6) ICD AND SJM RIGHT VENTRICULAR (RV) LEAD, WAS EXPLANTED DUE TO INFECTION. THE SALES REP WILL BE CONTACTED FOR FURTHER DETAILS REGARDING THIS EVENT. REF REPORT: MW5153854. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1231161 SONTRTIP IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT) LWS SORIN CRM SAS PS55D

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown (B)(6) ICD| CELERITY| SJM RIGHT VENTRICULAR LEAD