BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROTEGO PROMRI S 65

    MDR report key: 20717033 · Received November 18, 2024

    Report

    Report Number
    1028232-2024-06011
    Event Type
    Malfunction
    Date Received
    November 18, 2024
    Date of Event
    November 12, 2024
    Report Date
    January 27, 2025
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    NVY
    PMA / PMN Number
    P980023
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    COMBINATION PRODUCT: YES. -AS OF TODAY, THE MEDICAL DEVICE IS NOT AVAILABLE FOR ANALYSIS, THEREFORE THE DEVICE ITSELF COULD NOT BE INVESTIGATED. THE ANALYSIS IS THUS BASED ON THE INSPECTION OF THE MANUFACTURING DOCUMENTS OF THE DEVICE AS WELL AS ON THE PROVIDED DATA. THE QUALITY DOCUMENTS ACCOMPANYING THE MANUFACTURING PROCESS FOR THIS DEVICE WERE RE-INVESTIGATED. ALL PRODUCTION STEPS WERE PERFORMED ACCORDINGLY, AND IN PARTICULAR THE FINAL ACCEPTANCE TEST PROVED THE DEVICE FUNCTIONS TO BE AS SPECIFIED. THE ANALYSIS OF THE PROVIDED IEGM EPISODES NO. 183 FROM NOVEMBER 01, 2024; 178 FROM OCTOBER 25, 2024; 177 FROM OCTOBER 18, 2024; 174 FROM SEPTEMBER 26, 2024; 167 FROM AUGUST 16, 2024 AND 162 FROM JULY 15, 2024 REVEALED ARTIFACTS ON THE FF AND RV CHANNEL, WHICH LED TO OVERSENSING. IN EPISODE NO. 162 THE OVERSENSING ALSO RESULTED IN AN ABORTED ICD CHARGING. IN SPITE OF THE AVAILABLE INFORMATION, NO CONCLUSION CAN BE DRAWN REGARDING THE ROOT CAUSE OF THE CLINICAL OBSERVATION. AN ANALYSIS OF THE LEAD ITSELF WOULD BE NECESSARY TO DETERMINE THE ROOT CAUSE. SHOULD ADDITIONAL INFORMATION OR THE DEVICE ITSELF BECOME AVAILABLE FOR ANALYSIS, THE INVESTIGATION WILL BE UPDATED.

    Additional Manufacturer Narrative · 0

    COMBINATION PRODUCT: YES.

    Description of Event or Problem · 0

    OVERSENSING WAS REPORTED ON THE VENTRICULAR CHANNEL. THE LEAD WAS CAPPED AND A NEW LEAD WAS IMPLANTED. THE ICD WAS REPLACED TOO WITH AN UPGRADING SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2621280 PROTEGO PROMRI S 65 ICD LEAD NVY BIOTRONIK SE & CO. KG 394099

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization