BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTOVIS DR-T PROMRI

    MDR report key: 6062274 · Received October 27, 2016

    Report

    Report Number
    1028232-2016-04238
    Event Type
    Injury
    Date Received
    October 27, 2016
    Date of Event
    October 5, 2016
    Report Date
    October 5, 2016
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    NVN
    PMA / PMN Number
    P950037
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    WE RECEIVED YOUR EVENT DESCRIPTION FOR THE ABOVE MENTIONED DEVICE AND WOULD LIKE TO THANK YOU FOR SUPPORTING OUR POST-MARKET SURVEILLANCE. AS OF TODAY, THE MEDICAL DEVICE IS NOT AVAILABLE FOR ANALYSIS, THEREFORE THE DEVICE ITSELF COULD NOT BE INVESTIGATED. THE INFORMATION YOU PROVIDED HAS BEEN ENTERED INTO OUR QUALITY SYSTEM AS A COMPLAINT. THESE TYPES OF COMPLAINTS ARE USED TO EVALUATE SYSTEMS AND DEVICE PERFORMANCE THROUGHOUT OUR ORGANIZATION AND HELP TO MAINTAIN AND IMPROVE THE PERFORMANCE OF OUR DEVICES. SHOULD ADDITIONAL RELEVANT INFORMATION OR THE DEVICE ITSELF BECOME AVAILABLE, THE INVESTIGATION WILL BE UPDATED.

    Description of Event or Problem · 1

    UPON INTERROGATION, DEVICE HAD A BATTERY ERROR MESSAGE. GAS GAUGE ON THE PROGRAMMER SAID 60% LEFT BUT WAS GIVING A 6 MONTH BATTERY LONGEVITY. PERFORMED A RESET. DEVICE RETURNED TO NORMAL AND ACCURATE BATTERY ESTIMATION. DEVICE REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    712440 ENTOVIS DR-T PROMRI PACEMAKER NVN BIOTRONIK SE & CO. KG 371992

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR