BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSIA SR

    MDR report key: 2951626 · Received February 9, 2013

    Report

    Report Number
    9614453-2013-00049
    Event Type
    Malfunction
    Date Received
    February 9, 2013
    Report Date
    February 26, 2013
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    NVZ
    PMA / PMN Number
    P980035/S043
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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

    PRODUCT EVENT SUMMARY #(B)(4) - THE ACTUAL DEVICE WAS NOT RECEIVED FOR EVALUATION. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. THE CODE INDICATES THAT THE DEVICE DETECTED NOISE DURING THE CAPTURE DETECT WINDOW. THIS CODE IS ONLY FOR THE MOST RECENT TEST. IT CANNOT BE DETERMINES WHY VENTRICULAR CAPTURE MANAGEMENT HASN'T RUN SINCE 2012(B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PACEMAKER DID NOT COLLECT THE TRENDS ON THE CAPTURE MANAGEMENT DIAGNOSTIC. ENGINEERS HAVE NOT DETERMINED WHY THE DEVICE WOULD NOT DISPLAY CERTAIN MEASUREMENTS ON THE GRAPH. THE DEVICE IS STILL IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    55809 SENSIA SR PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ IPG MFG SWITZERLAND SESR01

    Patients

    Seq Age Sex Outcome Treatment
    1