BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENSIA SR

    MDR report key: 3991580 · Received August 8, 2014

    Report

    Report Number
    9614453-2014-01690
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    June 5, 2014
    Report Date
    June 5, 2014
    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).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE DEVICE WAS NOT RETURNED FOR ANALYSIS. HOWEVER, PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS RECEIVED AND ANALYZED. ANALYSIS OF THE DEVICE MEMORY INDICATED OVERSENSING DUE TO NON-PHYSIOLOGIC SIGNALS SENSING INTEGRITY COUNTER (SIC). ANALYST COMMENTED, AUTOMATIC LEAD DIAGNOSTICS SHOWS VENTRICULAR NON-PHYSIOLOGICAL SENSING DETECTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS HOSPITALIZED AFTER FALLS THAT OCCURRED. THE IMPLANTABLE PULSE GENERATOR (IPG) WAS NOTED TO EXHIBIT LOSS OF CAPTURE AND OVERSENSING WITH POCKET MANIPULATION. DIAGNOSTIC TESTING/TROUBLESHOOTING WAS PERFORMED. THE IPG WAS REPROGRAMMED AND REMAINS IN USE. IN ADDITION IT WAS NOTED THAT A RIGHT VENTRICULAR (RV) LEAD ALERT TRIGGERED FOR LOW PACING IMPEDANCE WITH A NUMBER OF VENTRICULAR TACHYCARDIA (VT) EPISODES THAT APPEARED TO BE NON-PHYSIOLOGICAL. THE RV LEAD WAS REPROGRAMMED AND REMAINS IN USE. HOWEVER, A POSSIBLE BATTERY CHANGE WITH RV LEAD REVISION IS SCHEDULED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    470507 SENSIA SR PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ IPG MFG SWITZERLAND SESR01

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R 5054-58 LEAD