BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIELLO S 60

    MDR report key: 17646168 · Received August 29, 2023

    Report

    Report Number
    1028232-2023-04285
    Event Type
    Malfunction
    Date Received
    August 29, 2023
    Report Date
    August 31, 2023
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    NVN
    PMA / PMN Number
    P950037
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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 · 0

    IT WAS REPORTED THAT AN ERROR WAS OBSERVED FOR AN OUT-OF-RANGE PACING IMPEDANCE MEASUREMENT. EFFORTS WERE UNSUCCESSFUL TO OBTAIN WHICH CHANNEL THE ALERT WAS GENERATED FOR AND THE SPECIFIC OUT OF RANGE MEASUREMENT. THE DEVICE WAS EXPLANTED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2). NO DEVICE DETAILS ARE AVAILABLE. RECEIVED VOLUNTARY ANONYMOUS MEDWATCH REPORT, MW5120244 AND 5120245 (DUPLICATES).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2185779 SIELLO S 60 PACING LEAD NVN BIOTRONIK SE & CO. KG 362702

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Hospitalization