BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENSIA

    MDR report key: 3153737 · Received June 8, 2013

    Report

    Report Number
    3008973940-2013-00071
    Event Type
    Injury
    Date Received
    June 8, 2013
    Date of Event
    March 22, 2013
    Report Date
    March 25, 2013
    Manufacturer
    MEDTRONIC SINGAPORE OPERATIONS
    Product Code
    NVZ
    PMA / PMN Number
    P980035
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    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. PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED AND ANALYZED. ANALYSIS REVEALED NO ANOMALIES. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AT THE SIX WEEK POST IMPLANT CHECK, THE DEVICE HAD A SUSPECTED PACING PROBLEM WITH THE ATRIAL IMPEDANCE GREATER THAN 9,999 OHMS. IT WAS NOTED THAT THE LEAD HAD NORMAL IMPEDANCE WHEN CONNECTED TO AN EXTERNAL ANALYZER. THE DEVICE WAS EXPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    255071 SENSIA PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ MEDTRONIC SINGAPORE OPERATIONS SEDR01

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R