BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLEXA PROMRI S DX 65/15

    MDR report key: 20380342 · Received October 6, 2024

    Report

    Report Number
    1028232-2024-05227
    Event Type
    Injury
    Date Received
    October 6, 2024
    Date of Event
    October 1, 2024
    Report Date
    July 16, 2025
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    NVY
    UDI-DI
    04035479158781
    PMA / PMN Number
    P980023
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    COMBINATION PRODUCT: YES.

    Additional Manufacturer Narrative · 0

    COMBINATION PRODUCT: YES. THE LEAD WAS EXPLANTED ON (B)(6) 2024. THE LEAD IS CURRENTLY NOT AVAILABLE FOR ANALYSIS. NO CONCLUSION CAN BE DRAWN BASED ON AVAILABLE INFORMATION AT THE MOMENT. THE FILE IS CLOSED. THE INVESTIGATION WILL BE RE-OPENED SHOULD ADDITIONAL DATA BECOME AVAILABLE.

    Additional Manufacturer Narrative · 0

    COMBINATION PRODUCT: YES. THE LEAD WAS EXPLANTED ON (B)(6) 2024. ON 04-MAR-2025 ADDITIONAL INFORMATION RECEIVED STATING THERE WAS OVERSENSING AND LEAD HAD RETRACTED TO THE RA/SVC LIKELY DUE TO VERY HIGH RV PRESSURES CAUSING DISLODGEMENT. UPON RECEIPT, THE LEAD UNDER COMPLAINT WAS SUBJECTED TO AN EXTENSIVE ANALYSIS. THE PERFORMANCE OF THE LEAD WAS SCRUTINIZED, INCLUDING A VISUAL, MECHANICAL AND ELECTRICAL INSPECTION. THE VISUAL ANALYSIS REVEALED A CUT INTO THE INSULATION 37.5 CM DISTAL TO THE IS-1 CONNECTOR PIN AND A DEFORMED RV SHOCK COIL, THESE DAMAGES MOST LIKELY RESULTED FROM THE EXPLANTATION PROCEDURE. HOWEVER, A THOROUGH ANALYSIS OF THE LEAD DID NOT SHOW ANY DEVIATIONS WHICH MIGHT HAVE LED TO THE REPORTED CLINICAL OBSERVATIONS. THE VALUES OF THE PARAMETERS MEASURED DURING THE MECHANICAL AND ELECTRICAL ANALYSIS WERE WITHIN THE TECHNICAL SPECIFICATIONS. PRIOR TO THE ANALYSIS OF THE DEVICE, 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. IN CONCLUSION, THE ANALYSIS DID NOT REVEAL ANY SIGN OF A MATERIAL OR MANUFACTURING PROBLEM.

    Description of Event or Problem · 0

    NOISE SEEN ON V AND A SIGNALS. NOISE ON V LEAD LEAD TO INAPPROPRIATE VF DETECTION AND SHOCK. LEAD CURRENTLY REMAINS IMPLANTED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.

    Description of Event or Problem · 0

    NOISE SEEN ON V AND A SIGNALS. NOISE ON V LEAD LEAD TO INAPPROPRIATE VF DETECTION AND SHOCK. LEAD CURRENTLY REMAINS IMPLANTED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2606948 PLEXA PROMRI S DX 65/15 ICD LEAD NVY BIOTRONIK SE & CO. KG 436909 04035479158781

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Female Hospitalization