BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASSURITY MRI

    MDR report key: 15414642 · Received September 13, 2022

    Report

    Report Number
    2017865-2022-37973
    Event Type
    Injury
    Date Received
    September 13, 2022
    Date of Event
    August 26, 2022
    Report Date
    February 16, 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
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PLEASE NOTE, THE MDR SUBMITTED ON 15 FEBURARY 2023 UNDER MDR-2022-38312-02 WAS SUBMITTED IN ERROR. ALL AVAILABLE INFORMATION WAS INCLUDED IN MDR-2022-38312-01 SUBMITTED ON 28 OCTOBER 2022. BECAUSE OF THIS, G3 LISTED IN MDR-2022-38312-02 (26 OCT 2022) WAS AN ERROR; G3 WAS NOT APPLICABLE AS NO NEW INFORMATION WAS RECEIVED OR PROVIDED IN THE MDR. IN THE EVENT THAT A G3 IS REQUIRED, THE CORRECT G3 WOULD BE 15 FEBURARY 2023 TO ALIGN WITH THE DATE MDR-2022-38312-02 WAS SUBMITTED.

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT WAS THE PROPHYLACTIC EXPLANT OF A DEVICE THAT WAS SUBJECT TO THE ZENEX, ASSURITY, ENDURITY LASER ADHESION PREPARATION FIELD SAFETY CORRECTION ACTION ISSUED ON 20 JULY 2022, WHICH APPLIES TO A SUBSET OF DEVICES DISTRIBUTED AND IMPLANTED OUTSIDE OF THE UNITED STATES. 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).

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT WAS THE PROPHYLACTIC EXPLANT OF A DEVICE THAT WAS SUBJECT TO THE ZENEX, ASSURITY, ENDURITY LASER ADHESION PREPARATION FIELD SAFETY CORRECTION ACTION ISSUED ON 20 JULY 2022, WHICH APPLIES TO A SUBSET OF DEVICES DISTRIBUTED AND IMPLANTED OUTSIDE OF THE UNITED STATES. 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

    IT WAS REPORTED THAT THE DEVICE WAS EXPLANTED AND REPLACED AS IT IS SUBJECT TO THE ZENEX, ASSURITY, ENDURITY LASER ADHESION PREPARATION FIELD SAFETY CORRECTION ACTION WHICH APPLIES TO A SUBSET OF DEVICES DISTRIBUTED AND IMPLANTED OUTSIDE OF THE UNITED STATES. THE PATIENT WAS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1969958 ASSURITY MRI IMPLANTABLE PACEMAKER PULSE GENERATOR LWP ST. JUDE MEDICAL, INC.(CRM-SYLMAR) PM2272 P000097032 05414734509589

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention