BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRATOS LV-T

    MDR report key: 2771465 · Received September 28, 2012

    Report

    Report Number
    1028232-2012-02440
    Event Type
    Malfunction
    Date Received
    September 28, 2012
    Date of Event
    August 1, 2012
    Report Date
    September 13, 2012
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    NKE
    PMA / PMN Number
    P070008
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WE WERE INFORMED THE DEVICE WAS RETURNED FOR ANALYSIS THE PACEMAKER HAD BEEN IMPLANTED FOR (B)(6) MONTHS. THE MANUFACTURING PROCESS FOR THIS DEVICE WAS REVIEWED. THE PRODUCTION DOCUMENTS DID NOT SHOW ANY ANOMALIES THAT COULD BE RELATED TO THE COMPLAINT. ALL MANUFACTURING STEPS HAD BEEN CARRIED OUT CORRECTLY. AFTER ITS RETURN, THE DEVICE UNDERWENT AN ELECTRICAL INCOMING GOODS INSPECTION AT AN AMBIENT TEMPERATURE OF 37 DEGREES C. THE PACEMAKER WAS INTERROGATED, AND THE ANTIBRADYCARDIC OUTPUT SIGNAL WAS CHECKED. THE IMPLANT PROVIDED THERAPY IN THE SAFE PROGRAM. IN A NEXT STEP, THE MEMORY CONTENT OF THE DEVICE WAS ANALYZED. THE CHECK SHOWED THAT THE PACEMAKER SWITCHED TO THE SAFETY PROGRAM BECAUSE OF DAMAGE TO THE MEMORY CONTENT. IN GENERAL, THE DEVICE IS CAPABLE TO DETECT DAMAGED MEMORY AREAS AND THEN TO SWITCH TO THE SAFE MODE AUTOMATICALLY. AN ANTIBRADYCARDIC THERAPY FUNCTION IS ENSURED IN THE SAFE PROGRAM. IN ADDITION, THE ANALYSIS OF THE MEMORY CONTENT SHOWED THAT IT WAS DAMAGED IN SUCH A WAY THAT A CORRECTION BY RE-INITIALIZATION WAS NOT POSSIBLE. FURTHERMORE, THE ANALYSIS OF THE RETURNED DATA SHOWED THAT THE DEVICE ALREADY SWITCHED TO ERI ON (B)(6) 2012. THE CHARGE DRAWN FROM THE BATTERY WAS CHECKED. THE BATTERY DEPLETION PROVED TO BE IN ACCORDANCE WITH EXPECTATIONS. IN SUMMARY, THE ANALYSIS IDENTIFIED DAMAGED MEMORY CONTENT, WHICH LED TO THE CLINICAL OBSERVATION. THE CAUSE FOR THE DAMAGED MEMORY CONTENT COULD NOT BE DETERMINED. IT CANNOT BE RULED OUT THAT EXTERNAL INFLUENCES, SUCH AS STRONG ELECTROMAGNETIC FIELDS, WERE THE CAUSE OF THE DAMAGED MEMORY CONTENT.

    Additional Manufacturer Narrative · 1

    OUS MDR.

    Description of Event or Problem · 1

    OUS MDR - IT WAS REPORTED THAT THIS PACEMAKER HAD TO BE INITIALIZED REPEATEDLY; EVEN AFTER PRECEDING RE-INITIALIZATION. IT WAS EXPLANTED AFTER CONSULTATION AND EXCHANGED.

    Description of Event or Problem · 1

    OUS MDR - IT WAS REPORTED THAT THIS PACEMAKER HAD TO BE INITIALIZED REPEATEDLY; EVEN AFTER PRECEDING RE-INITIALIZATION. IT WAS EXPLANTED AFTER CONSULTATION AND EXCHANGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STRATOS LV-T CRT PACEMAKER NKE BIOTRONIK SE & CO. KG 338202

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization