BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STRATOS LV

    MDR report key: 3193459 · Received June 27, 2013

    Report

    Report Number
    1028232-2013-01792
    Event Type
    Injury
    Date Received
    June 27, 2013
    Date of Event
    May 14, 2013
    Report Date
    June 11, 2013
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    NKE
    PMA / PMN Number
    P070008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT, THE DEVICE WAS INTERROGATED, REVEALING THE BATTERY STATUS OK. THE DEVICE WAS IMPLANTED FOR 9 MONTHS. THE INSPECTION OF THE PACEMAKER MEMORY REVEALED NO ANOMALIES. THERE WERE NO INDICATIONS OF A DEVICE MALFUNCTION. THE PACEMAKER WAS SUBJECTED TO AN ELECTRICAL ANALYSIS. THE ABILITY OF THE DEVICE TO DELIVER THERAPIES WAS VERIFIED. THE ANTI-BRADYCARDIA PACING PULSES PROVED TO BE FLAWLESS AND IN AMPLITUDE AND FREQUENCY AS PROGRAMMED. IN SUMMARY, THE DEVICE IS FULLY FUNCTIONAL. THERE WAS NO INDICATION OF A MATERIAL OR MANUFACTURING PROBLEM.

    Description of Event or Problem · 1

    THE PATIENT WAS EXPERIENCING DIAPHRAGMATIC STIMULATION. THE PHYSICIAN CHOSE TO REPLACE THIS DEVICE WITH A DIFFERENT CRT-P BECAUSE IT HAD MORE PROGRAMMING OPTIONS. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291978 STRATOS LV CRT-P NKE BIOTRONIK SE & CO. KG 338200

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization