BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENSIA DR

    MDR report key: 1864715 · Received October 12, 2010

    Report

    Report Number
    6000144-2010-05253
    Event Type
    Injury
    Date Received
    October 12, 2010
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    NVZ
    PMA / PMN Number
    P980035/S043
    Removal / Correction Number
    ASKU
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE MIGRATED TO THE LEFT SUBCUTANEOUS MAMMARY REGION. THE LEAD HAD A SLIGHT KINK IN THE PROXIMAL PORTION. KINKED PORTION OF LEAD WAS INSPECTED AND DEEMED TO BE INTACT. DEVICE WAS PLACED BACK IN THE POCKET AND LEADS CONNECTED. THE LEAD AND DEVICE ARE STILL IN USE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SENSIA DR IMPLANTABLE PULSE GENERATOR NVZ MEDTRONIC MED REL, INC. SEDR01 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention 5068 IMPLANTABLE PACING LEAD