BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROTEGO PROMRI SD 65/16

    MDR report key: 4211035 · Received October 29, 2014

    Report

    Report Number
    1028232-2014-003754
    Event Type
    Injury
    Date Received
    October 29, 2014
    Date of Event
    October 7, 2014
    Report Date
    October 14, 2014
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    NVY
    PMA / PMN Number
    P980023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    OUS MDR - ON THE (B)(6) 2014 AFTER THE FOLLOW-UP POST IMPLANT, THE SENSING WAS LOW AND THRESHOLD WAS HIGH FOR BOTH THE RA AND RV LEADS. SO A THORACIC X-RAY EXAM WAS PERFORMED DISCOVERING THAT THE LEADS WERE DISLODGED. IT WAS DECIDED TO REPOSITION THEM. THIS LEAD WAS NOT EASILY REPOSITIONED; IN FACT THE SCREW DID NOT EASILY RETRACT. EVENTUALLY THE FINAL POSITION OF THE LEAD WAS SUCCESSFUL AND GOOD NUMBERS WERE OBTAINED. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED. ALL AVAILABLE INFORMATION SUGGESTS THIS LEAD REMAINS ACTIVELY IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    691659 PROTEGO PROMRI SD 65/16 ICD LEAD NVY BIOTRONIK SE & CO. KG 399414

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization