BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INCHECK PATIENT ASSISTANT

    MDR report key: 3861916 · Received June 10, 2014

    Report

    Report Number
    3004593495-2014-00022
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    April 14, 2014
    Report Date
    June 10, 2014
    Manufacturer
    PLEXUS MANUFACTURING SDN. BHD
    Product Code
    NVZ
    PMA / PMN Number
    P980035
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    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).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT ASSISTANT (PA) WAS NOT WORKING PROPERLY. THE PA WOULD BEEP AND FLASH THE GREEN LIGHT WHEN THE QUERY BUTTON WAS PRESSED OVER THE PATIENT¿S DEVICE. THE PATIENT WAS IN ATRIAL FIBRILLATION (AF), HOWEVER, THE ACTIVATOR WAS NOT DETECTING THE AF. MULTIPLE SEQUENCES OF ANTI-TACHYCARDIA PACING (ATP) WERE DELIVERED, BUT NO THERAPIES WERE DELIVERED. TECHNICAL SUPPORT (TS) SUGGESTED TO END EPISODE BY DECREASING SENSITIVITY TO FORCE UNDERSENSING AND WATCH FOR EPISODE TO END AND THEN INTERROGATE THE DEVICE. PA WAS REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT ASSISTANT (PA) WAS NOT WORKING PROPERLY. THE PA WOULD BEEP AND FLASH THE GREEN LIGHT WHEN THE QUERY BUTTON WAS PRESSED OVER THE PATIENT¿S DEVICE. THE PATIENT WAS IN ATRIAL FIBRILLATION (AF), HOWEVER THE PA WAS UNABLE TO COMMUNICATE BY QUERYING THE IMPLANTED DEVICE. MULTIPLE SEQUENCES OF ANTI-TACHYCARDIA PACING (ATP) WERE DELIVERED, BUT NO THERAPIES WERE DELIVERED. TECHNICAL SUPPORT (TS) SUGGESTED TO END EPISODE BY DECREASING SENSITIVITY TO FORCE UNDERSENSING AND WATCH FOR EPISODE TO END AND THEN INTERROGATE THE DEVICE. PA WAS REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340080 INCHECK PATIENT ASSISTANT PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ PLEXUS MANUFACTURING SDN. BHD 2696

    Patients

    Seq Age Sex Outcome Treatment
    1 00077 YR Required Intervention