BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENSIA S

    MDR report key: 2813310 · Received October 31, 2012

    Report

    Report Number
    6000094-2012-02499
    Event Type
    Injury
    Date Received
    October 31, 2012
    Manufacturer
    MEDTRONIC S.A.
    Product Code
    NVZ
    PMA / PMN Number
    P980035/S043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. EVALUATION SUMMARY: (B)(4) THE DEVICE WAS RETURNED, ANALYZED, AND ANALYSIS OF THE DEVICE REVEALED NORMAL BATTERY DEPLETION; MEETS EXPECTED LONGEVITY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE HAD NO TELEMETRY AND HAD REACHED ERI (ELECTIVE REPLACEMENT INDICATOR) BEFORE FIVE YEARS. THE DEVICE WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SENSIA S IMPLANTABLE PULSE GENERATOR NVZ MEDTRONIC S.A. SES01

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R