BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INGENIO

    MDR report key: 17003697 · Received May 25, 2023

    Report

    Report Number
    2124215-2023-26310
    Event Type
    Injury
    Date Received
    May 25, 2023
    Date of Event
    May 5, 2023
    Report Date
    September 7, 2023
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LWW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS PRODUCT HAS NOT BEEN RETURNED TO BOSTON SCIENTIFIC, AND AS A RESULT, LABORATORY ANALYSIS COULD NOT BE CONDUCTED. PLEASE REFER TO B5 DESCRIBE EVENT OR PROBLEM FOR MORE INFORMATION REGARDING THE SPECIFIC CIRCUMSTANCES OF THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS PACEMAKER WAS EXHIBITING OVERSENSING NOISE AND THE PATIENT REPORTED FEELING FATIGUE, DYSPNEA AND DISCOMFORT. IT WAS NOT KNOWN IF THE PATIENT EXPERIENCED PACING INHIBITION OR ASYSTOLE. ADDITIONALLY, THE NURSE INDICATED THAT THE DEVICE WENT INTO BACKUP MODE VVI 40 BPM STATUS WHICH COULD BE CLEARED AFTER DEVICE INTERROGATION. WHEN THE BACKUP MODE WAS CLEARED FROM THE DEVICE, THE DEVICE REVERTED TO NORMAL VVIR MODE 60 BPM. THERE WAS AN ALERT MESSAGE INDICATING APPROXIMATE TIME TO EXPLANT IS 4 MONTHS. BOSTON SCIENTIFIC TECHNICAL SERVICES PROVIDED TROUBLESHOOTING OPTIONS AND SUGGESTED THAT THE HEALTHCARE PROFESSIONAL EVALUATE THE COMPETITOR LEAD FOR POTENTIAL LEAD ISSUE. THE PLAN IS TO REPLACE THIS PACEMAKER AS SOON AS POSSIBLE. THE COMPETITOR LEAD WAS TESTED DURING THE REPLACEMENT PROCEDURE WITHOUT SEEING ABNORMALITIES. SUBSEQUENTLY, THIS DEVICE WAS REPLACED WITH A COMPETITOR PACEMAKER. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THE PRODUCT WAS RETURNED TO BOSTON SCIENTIFIC BUT HAS BECOME LOST IN TRANSIT. SHOULD THIS PRODUCT BE RECEIVED IN THE FUTURE, AN UPDATED REPORT WILL BE PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS PACEMAKER WAS EXHIBITING OVERSENSING NOISE AND THE PATIENT REPORTED FEELING FATIGUE, DYSPNEA AND DISCOMFORT. IT WAS NOT KNOWN IF THE PATIENT EXPERIENCED PACING INHIBITION OR ASYSTOLE. ADDITIONALLY, THE NURSE INDICATED THAT THE DEVICE WENT INTO BACKUP MODE VVI 40 BPM STATUS WHICH COULD BE CLEARED AFTER DEVICE INTERROGATION. WHEN THE BACKUP MODE WAS CLEARED FROM THE DEVICE, THE DEVICE REVERTED TO NORMAL VVIR MODE 60 BPM. THERE WAS AN ALERT MESSAGE INDICATING APPROXIMATE TIME TO EXPLANT IS 4 MONTHS. BOSTON SCIENTIFIC TECHNICAL SERVICES PROVIDED TROUBLESHOOTING OPTIONS AND SUGGESTED THAT THE HEALTHCARE PROFESSIONAL EVALUATE THE COMPETITOR LEAD FOR POTENTIAL LEAD ISSUE. THE PLAN IS TO REPLACE THIS PACEMAKER AS SOON AS POSSIBLE. THE COMPETITOR LEAD WAS TESTED DURING THE REPLACEMENT PROCEDURE WITHOUT SEEING ABNORMALITIES. SUBSEQUENTLY, THIS DEVICE WAS REPLACED WITH A COMPETITOR PACEMAKER. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    650492 INGENIO PULSE-GENERATOR, SINGLE CHAMBER, SINGLE LWW BOSTON SCIENTIFIC CORPORATION J172 101973

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Male Hospitalization| R