BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURITY MRI

    MDR report key: 15529348 · Received October 3, 2022

    Report

    Report Number
    2017865-2022-40047
    Event Type
    Injury
    Date Received
    October 3, 2022
    Date of Event
    September 2, 2022
    Report Date
    February 16, 2023
    Manufacturer
    ABBOTT
    Product Code
    LWP
    UDI-DI
    05414734509602
    PMA / PMN Number
    P140033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    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

    PLEASE NOTE, THE MDR SUBMITTED ON 15 FEBURARY 2023 UNDER MDR-2022-41605-02 WAS SUBMITTED IN ERROR. ALL AVAILABLE INFORMATION WAS INCLUDED IN MDR-2022-41605-01 SUBMITTED ON 17 JANUARY 2023. BECAUSE OF THIS, G3 LISTED IN MDR-2022-41605-02 (B)(6) 2023) 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-2022-41605-02 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).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEVICE WAS PROPHYLACTICALLY 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. NO MALFUNCTION WAS REPORTED, AND THE PATIENT IS IN STABLE CONDITION WITH NO ADVERSE CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2609694 ENDURITY MRI IMPLANTABLE PACEMAKER PULSE GENERATOR LWP ABBOTT PM2172 P000092600 05414734509602

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other