BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLIA S 53

    MDR report key: 2860140 · Received November 29, 2012

    Report

    Report Number
    1028232-2012-03019
    Event Type
    Injury
    Date Received
    November 29, 2012
    Date of Event
    October 11, 2012
    Report Date
    November 16, 2012
    Manufacturer
    BIOTRONIK SE AND CO. KG
    Product Code
    DTB
    PMA / PMN Number
    P950037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    OUS MDR - THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE ANALYSIS IS THEREFORE, BASED ON THE INSPECTION OF THE QUALITY DOCUMENTS ASSOCIATED WITH THE MANUFACTURE OF THIS PARTICULAR DEVICE. 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 WHICH MIGHT BE RELATED TO THE CLINICAL OBSERVATION. IN SUMMARY, THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE REVIEW OF THE QUALITY DOCUMENTS CONFIRMED A REGULAR DEVICE MANUFACTURING.

    Description of Event or Problem · 1

    OUS MDR - THIS LEAD WAS FOUND TO BE DISLODGED AND IN A CAUDAL POSITION WITHIN THE ATRIUM. IT WAS SUCCESSFULLY REVISED. THIS LEAD REMAINS IMPLANTED AND THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOLIA S 53 PACER LEAD DTB BIOTRONIK SE AND CO. KG 377177

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization