BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENSIA DR

    MDR report key: 2123441 · Received June 14, 2011

    Report

    Report Number
    6000144-2011-02270
    Event Type
    Injury
    Date Received
    June 14, 2011
    Date of Event
    March 1, 2011
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    NVZ
    PMA / PMN Number
    P980035/S043
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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. EVALUATION SUMMARY: (B)(4) THE DEVICE WAS RETURNED AND ANALYSIS FOUND NO ANOMALIES. IT WAS NOTED THAT THERE WAS GROMMET DAMAGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE DEVICE CHANGE OUT, THE PATIENT EXPERIENCED AN ASYSTOLE EPISODE. THE DEVICE HAD ISSUES WITH SENSING DIFFICULTY AND NO PACING OUTPUT. THE DEVICE WAS IN BIPOLAR WHEN OUT OF THE POCKET. THE DEVICE WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN 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 Hospitalization| L| R 5092 IMPLANTABLE PACING LEAD| 5076 IMPLANTABLE PACING LEAD