BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENTUS PROMRI OTW QP S-85/49

    MDR report key: 10877913 · Received November 20, 2020

    Report

    Report Number
    1028232-2020-05076
    Event Type
    Malfunction
    Date Received
    November 20, 2020
    Date of Event
    October 27, 2020
    Report Date
    October 27, 2020
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    OJX
    UDI-DI
    04035479145606
    PMA / PMN Number
    P070008
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    UPON RECEIPT, THE LEAD UNDER COMPLAINT WAS SUBJECTED TO AN EXTENSIVE ANALYSIS. THE ANALYSIS REVEALED CUTS INTO THE INSULATION (APPROX. 17 CM AND 36 CM DISTAL TO THE IS-4 CONNECTOR PIN), WHICH MOST LIKELY RESULTED FROM THE EXTRACTION PROCEDURE. A THOROUGH ANALYSIS OF THE LEAD DID NOT SHOW ANY DEVIATIONS WHICH MIGHT HAVE LED TO THE REPORTED DISLODGEMENT. THE MANUFACTURING PROCESS FOR THIS DEVICE WAS RE-INVESTIGATED. ALL PRODUCTION STEPS HAD BEEN PERFORMED ACCORDINGLY. THERE WAS NO SIGN OF ANY INCONSISTENCY DURING THE MANUFACTURING PROCESS. IN CONCLUSION, THE ANALYSIS DID NOT REVEAL ANY SIGN OF A MATERIAL OR MANUFACTURING PROBLEM.

    Description of Event or Problem · 1

    LEFT VENTRICULAR LEAD DISLODGEMENT AS SHOWED IN X-RAY IMAGE. THE PHYSICIAN DECIDED TO EXTRACT THE LEAD AND TO IMPLANT A NEW ONE (QP L 85/49) IN THE SAME VESSEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1338522 SENTUS PROMRI OTW QP S-85/49 LV LEAD OJX BIOTRONIK SE & CO. KG 406082 04035479145606

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization