BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERSA DR

    MDR report key: 1925792 · Received December 14, 2010

    Report

    Report Number
    6000144-2010-06346
    Event Type
    Malfunction
    Date Received
    December 14, 2010
    Date of Event
    October 5, 2010
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    NVZ
    PMA / PMN Number
    P980035/S043
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, 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: THE DEVICE WERE RETURNED AND ANALYZED. (B)(4) NO ANOMALIES WERE FOUND. IT WAS NOTED THERE WAS GROMMET DAMAGE. (B)(4) NO ANOMALIES WERE FOUND. IT WAS NOTED THERE WAS GROMMET DAMAGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IMPLANT WAS ATTEMPTED USING TWO DIFFERENT DEVICES, BUT OVERSENSING, FLUID INGRESS, AND CROSSTALK OCCURRED. ANOTHER DEVICE WAS IMPLANTED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERSA DR IMPLANTABLE PULSE GENERATOR NVZ MEDTRONIC MED REL, INC. VEDR01 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Other