BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SELOX JT 53

    MDR report key: 2113633 · Received May 24, 2011

    Report

    Report Number
    1028232-2011-01152
    Event Type
    Malfunction
    Date Received
    May 24, 2011
    Report Date
    May 15, 2011
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    NVZ
    PMA / PMN Number
    P950037
    Product Problem
    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. IN ADDITION, NO SPECIFIC INFO ON THE CLINICAL OBSERVATION WAS RECEIVED. THE ANALYSIS IS THEREFORE BASED ON THE INSPECTION OF THE QUALITY DOCUMENTS ASSOCIATED WITH THE MANUFACTURE OF THIS PARTICULAR DEVICE. THE MFG PROCESS FOR THIS DEVICE WAS RE-INVESTIGATED. ALL PRODUCTION STEPS HAD BEEN PERFORMED ACCORDINGLY. THERE WAS NO SIGN OF ANY INCONSISTENCY DURING THE MFG PROCESS WHICH MIGHT BE RELATED TO THE CLINICAL OBSERVATION. IN CASE THE LEAD IS EXPLANTED, IT WOULD BE HELPFUL TO SEND THIS BIOTRONIK FOR ANALYSIS. IN SUMMARY, THE REVIEW OF THE QUALITY DOCUMENTS CONFIRMED A REGULAR DEVICE MFG.

    Description of Event or Problem · 1

    OUS MDR - IT WAS REPORTED THAT THE LEADS DID NOT WORK. THERE WERE NO DATES OR ANY ADDITIONAL INFO PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SELOX JT 53 PACER LEAD NVZ BIOTRONIK SE & CO. KG 346368

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other