BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REOCOR S

    MDR report key: 19919702 · Received August 6, 2024

    Report

    Report Number
    1028232-2024-04140
    Event Type
    Malfunction
    Date Received
    August 6, 2024
    Date of Event
    July 18, 2024
    Report Date
    December 11, 2024
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    OVJ
    PMA / PMN Number
    P950037
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPON RECEIPT, THE EXTERNAL PACEMAKER WAS SUBJECTED TO AN EXTENSIVE ANALYSIS. WITHIN THIS ANALYSIS THE DEVICE WAS VISUALLY, MECHANICALLY AND FUNCTIONALLY INSPECTED. THE QUALITY DOCUMENTS ASSOCIATED WITH THIS DEVICE WERE RE-INVESTIGATED. THE REVIEW OF THESE QUALITY DOCUMENTS DID NOT SHOW ANY DEVIATION. DURING THE ANALYSIS OF THE DEVICE ITSELF, THE CLINICAL OBSERVATION COULD NOT BE CONFIRMED. THE DEVICE PROVED TO BE FULLY FUNCTIONAL. ALL MEASUREMENT RESULTS WERE WITHIN THE SPECIFICATIONS. THE ABILITY OF THE DEVICE TO SENSE CARDIAC SIGNALS AS WELL AS TO DELIVER ANTI-BRADYCARDIA THERAPY WAS TESTED AND DID NOT SHOW ANY DEVIATION. NO STIMULATION INTERRUPTIONS WERE DETECTED DURING ANALYSIS, EVEN DURING A LONG-TERM PACING TEST AND UNDER VIBRATION. SINCE IT WAS STATED THAT A SPECIFIC FUTJITSU BATTERY WAS USED, THIS WAS ALSO CONSIDERED. IT IS POSSIBLE THAT THE BATTERY USED (FUJITSU 6F22U (S)) HAS SHORTER CONTACTS THAN THE RECOMMENDED BATTERY TYPE. HOWEVER, THIS SHOULD NOT AFFECT THE BEHAVIOR DESCRIBED, SINCE IN THE CASE OF AN INTERRUPTION OF THE BATTERY CONTACTS, THE DEVICE CONTINUES TO STIMULATE VIA THE BACKUP PACING FUNCTION. NEVERTHELESS, THE USE OF THIS BATTERY TYPE IS NOT RECOMMENDED. AS THE DEVICE WORKED AS EXPECTED AND WITHIN THE SPECIFICATIONS, IT IS HAS TO BE ASSUMED THAT THE STIMULATION WAS INTERRUPTED DUE TO AN INADEQUATE CONTACT OF A CABLE, ADAPTER OR THE ELECTRODES ITSELF. IT IS THEREFORE POSSIBLE THAT A VIBRATION CAUSED A CONTACT INTERRUPTION AND THUS AN INTERRUPTION OF THE STIMULATION. IN CONCLUSION, THE DEVICE PROVED TO BE FULLY FUNCTIONAL. THEREFORE, IT HAS TO BE ASSUMED, THAT AN INADEQUATE CONTACT OF THE CONNECTED CABLES, ADAPTERS OR ELECTRODES HAS LED TO THE INTERRUPTION OF THE STIMULATION. DESPITE THE DEVICE WAS FULLY FUNCTIONAL AND ALL MEASUREMENT RESULTS WERE WITHIN THE SPECIFICATION, THE MAIN CIRCUIT BOARD AS WELL AS THE BATTERY COMPARTMENT WERE REPLACED AT THE CUSTOMERS REQUEST. THE VISUAL, MECHANICAL AND FUNCTIONAL ANALYSIS REVEALED NO INDICATION OF A MATERIAL OR MANUFACTURING PROBLEM.

    Description of Event or Problem · 0

    WHEN THE PATIENT WAS BEING TRANSFERRED TO THE BED DURING NORMAL USE, THE DEVICE SUDDENLY STOPPED WORKING AND TEMPORARILY ARRESTED (CARDIAC ARREST). THE SENSE, PACE AND LOW BATTERY LIGHTS ALL LIT UP AND AN ALARM SOUNDED. AFTER REPLACING THE BATTERY WITH A NEW ONE, THE DEVICE WAS RESTARTED AND READY TO USE. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1673845 REOCOR S EXTERNAL PACEMAKER OVJ BIOTRONIK SE & CO. KG 365528

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization