BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC.SIGMA

    MDR report key: 2935149 · Received January 30, 2013

    Report

    Report Number
    2647346-2013-00001
    Event Type
    Injury
    Date Received
    January 30, 2013
    Date of Event
    January 1, 2013
    Report Date
    January 1, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO, MED REL
    Product Code
    NVZ
    PMA / PMN Number
    P980035
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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. (B)(4). THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER AND WILL NOT BE EVALUATED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE "PHYSICIAN SAW SOME OF THE PATIENT HEART RATES 140-147 BEATS PER MINUTE. IT WAS NOTED TO POSSIBLY BE DUE TO RATE RESPONSE. THE PHYSICIAN CALLING IN STATED THAT HE IS NOT AN EP PHYSICIAN. THE PHYSICIAN NOTED THAT THE PATIENT WAS GOING TO HAVE THE DEVICE REPLACED AND REMAINS IN USE AT THIS TIME. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    40928 MEDTRONIC.SIGMA PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ MDT PUERTO RICO OPERATIONS CO, MED REL SSR303B

    Patients

    Seq Age Sex Outcome Treatment
    1 00021 YR Hospitalization| R 4965 IMPLANTABLE PACING LEAD