BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIGMA 300 DR

    MDR report key: 3992234 · Received August 8, 2014

    Report

    Report Number
    3004209178-2014-14884
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Date of Event
    May 5, 2014
    Report Date
    May 5, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO
    Product Code
    NVZ
    PMA / PMN Number
    P980035
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    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. CONCOMITANT MEDICAL PRODUCTS: 4058M58 LEAD, (B)(6) 1995. (B)(4).

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) HAD MOVED. IT WAS RECOMMENDED TO THE PATIENT THAT THEY SEE THEIR CARDIOLOGIST. FOLLOW-UP RECEIVED FROM THE PHYSICIAN'S NURSE REVEALED THAT THE PATIENT HAD BEEN SEEN, THERE ARE NO ISSUES WITH THE DEVICE, AND "THE DEVICE IS DOING GOOD." THE DEVICE IS STILL IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    469377 SIGMA 300 DR PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ MEDTRONIC PUERTO RICO SDR303B

    Patients

    Seq Age Sex Outcome Treatment
    1 00077 YR 4058M52 LEAD