BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASSURITY MRI

    MDR report key: 15936345 · Received December 7, 2022

    Report

    Report Number
    8030904-2022-00002
    Event Type
    Injury
    Date Received
    December 7, 2022
    Date of Event
    December 6, 2022
    Report Date
    January 3, 2023
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
    Product Code
    LWP
    UDI-DI
    05414734509589
    PMA / PMN Number
    P140033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION - D3 - MANUFACTURER INFORMATION IN THIS SECTION MISTAKENLY REPRESENTED ST. JUDE MEDICAL SYSTEMS AB (UPPSALA) AS OPPOSED TO ST. JUDE MEDICAL, INC.(CRM-SYLMAR) IN PREVIOUS REPORT ON 07 DEC 2022. CORRECTION - MFR REPORT NUMBER - MFR REPORT NUMBER WAS MISTAKENLY POPULATED AS 8030904 AS OPPOSED TO 2017865 IN PREVIOUS REPORT ON 07 DEC 2022.

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED DUE TO ADVISORY WITH NO ALLEGATION OF A MALFUNCTION. VISUAL INSPECTION OF THE DEVICE AND HEADER ATTACHMENT AREA DID NOT FIND ANY ANOMALIES. INTERROGATION OF THE DEVICE INDICATED BATTERY VOLTAGE AND CURRENT WITHIN NORMAL RANGE WHEN RECEIVED. BASED ON THIS INFORMATION, THE DEVICE WAS FOUND TO COMMUNICATE APPROPRIATELY WITH A MERLIN PROGRAMMER AND HAS NOT REACHED THE ELECTIVE REPLACEMENT INDICATOR (ERI).

    Description of Event or Problem · 0

    THE DEVICE IS INCLUDED IN THE ZENEX, ASSURITY, ENDURITY LASER ADHESION PREPARATION ADVISORY ISSUED BY ABBOTT ON 20 JULY 2022 FOR A SUBSET OF DEVICES DISTRIBUTED AND IMPLANTED OUTSIDE OF THE UNITED STATES. THE PACEMAKER WAS EXPLANTED AND REPLACED. THERE WERE NO PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2403799 ASSURITY MRI IMPLANTABLE PACEMAKER PULSE GENERATOR LWP ST. JUDE MEDICAL, INC.(CRM-SYLMAR) PM2272 P000122515 05414734509589

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention