BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SD01 65/16

    MDR report key: 11882785 · Received May 26, 2021

    Report

    Report Number
    1028232-2021-02859
    Event Type
    Malfunction
    Date Received
    May 26, 2021
    Date of Event
    November 25, 2020
    Report Date
    May 20, 2021
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS CURRENTLY NOT AVAILABLE FOR ANALYSIS. NO CONCLUSION CAN BE DRAWN AT THIS TIME. NO ADDITIONAL INFORMATION IS AVAILABLE AT THE MOMENT. THE FILE IS CLOSED. THE INVESTIGATION WILL BE RE-OPENED SHOULD ADDITIONAL DATA BECOME AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED APPROXIMATELY 77 MONTHS AFTER THE IMPLANTATION, THAT THERE WAS A SUDDEN INCREASE OF SHOCK IMPEDANCE (GREATER THAN 150 OHM). THE DEVICE HAS BEEN EXPLANTED AND A NEW LEAD WAS IMPLANTED. AN EXPLANT DATE WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    787644 SD01 65/16 LWS BIOTRONIK SE & CO. KG 365486

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization