BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSIA DR

    MDR report key: 3862613 · Received June 10, 2014

    Report

    Report Number
    9614453-2014-01356
    Event Type
    Malfunction
    Date Received
    June 10, 2014
    Date of Event
    April 22, 2014
    Report Date
    April 22, 2014
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    NVZ
    PMA / PMN Number
    P980035
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    HEALTH PROFESSIONAL

    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. CONCOMITANT PRODUCT : 4524-53 LEAD IMPLANTED (B)(6) 2001.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD TRIGGERED A LEAD WARNING IN THE BIPOLAR PACING CONFIGURATION ABOUT 13 MONTHS EARLIER AND DIAGNOSTIC DATA SHOWED "59% UNSUCCESSFUL PACES" SINCE THAT TIME. IT WAS ALSO REPORTED THAT THE PATIENT HAS A "LOOSE POCKET" WHICH ALLOWS THE DEVICE TO "STAND UPRIGHT" WHEN THE PATIENT IS LAYING DOWN. BECAUSE OF THE DEVICE ISSUE, THE CLINICIAN WAS HESITANT TO CHANGE THE PACING CONFIGURATION TO UNIPOLAR, BUT IT WILL BE TESTED AND POSSIBLY REPROGRAMMED IF THE SENSING AND PACING ARE APPROPRIATE. THE LEAD AND DEVICE REMAINS 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
    341254 SENSIA DR PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ IPG MFG SWITZERLAND SEDRL1

    Patients

    Seq Age Sex Outcome Treatment
    1 4024 LEAD