BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENSIA

    MDR report key: 2964391 · Received February 15, 2013

    Report

    Report Number
    9614453-2013-00413
    Event Type
    Injury
    Date Received
    February 15, 2013
    Report Date
    December 12, 2012
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    NVZ
    PMA / PMN Number
    P980035
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE HAD A PACING AND SENSING PROBLEM. THE DEVICE WAS VENTRICULAR PACING DURING CONDUCTED ATRIAL FIBRILLATION AND THERE WAS CONCERN WITH POSSIBLE PACING IN T-WAVES. IT WAS DETERMINED THE DEVICE HAD NOISE REVERSION. REPROGRAMMING WAS RECOMMENDED AND 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
    68303 SENSIA PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ IPG MFG SWITZERLAND SESR01

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R