BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENDRIL MRI

    MDR report key: 8642772 · Received May 24, 2019

    Report

    Report Number
    2938836-2019-04112
    Event Type
    Injury
    Date Received
    May 24, 2019
    Date of Event
    May 10, 2019
    Report Date
    June 12, 2019
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)
    Product Code
    DXY
    UDI-DI
    05414734504621
    PMA / PMN Number
    P140033
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED.

    Description of Event or Problem · 1

    CORRECTION: IT WAS REPORTED THAT INCREASE IN PACING THRESHOLD WAS OBSERVED ON RIGHT ATRIAL LEAD. PROGRAMMING CHANGES WERE MADE. ADDITIONAL INFORMATION: NEW INFORMATION RECEIVED NOTES THAT LOSS OF CAPTURE WAS OBSERVED. DEVICE WAS REPROGRAMMED. THE PATIENT HAD SURGERY. FURTHER INFORMATION WAS REQUESTED AND NOT AVAILABLE YET.

    Description of Event or Problem · 1

    AE REL TO IMPLANT PROCEDURE: N. AE REL TO PROTOCOL PROCEDURE: N. AE RELATED TO PG/IPG: N. AE RELATED TO RA LEAD: Y. AE RELATED TO RV LEAD: N. AE RELATED TO SYSTEM: N. EVENT DESCRIPTION: ELEVATED PACING THRESHOLDS. EVENT DESCRIPTION- OTHER, SPEC: AE EVENT DETAILS: RA THRESHOLD >[email protected]. PATIENT'S ETHNICITY: NOT HISPANIC OR LATINO. PATIENT'S RACE: WHITE. PATIENT NUMBER: (B)(6). CLINICAL STUDY PATIENT ID: (B)(6). STATUS OF ADVERSE EVENT: RESOLVED. TREATMENT: DEVICE REPROGRAMMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    436112 TENDRIL MRI PERMANENT PACEMAKER ELECTRODE DXY ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) LPA1200M/52 S000062864 05414734504621

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention