BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RELIA S

    MDR report key: 2946116 · Received February 6, 2013

    Report

    Report Number
    3008973940-2013-00001
    Event Type
    Injury
    Date Received
    February 6, 2013
    Report Date
    March 18, 2013
    Manufacturer
    MEDTRONIC SINGAPORE OPERATIONS
    Product Code
    NVZ
    PMA / PMN Number
    P980035
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY #PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED AND ANALYZED. ANALYSIS OF THE DEVICE REVEALED NORMAL BATTERY DEPLETION.

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THIS EVENT OCCURRED OUTSIDE THE U.S 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 DEVICE HAD HIGH OUTPUT DUE TO HIGH THRESHOLD ON THE LEAD. THE DEVICE WAS EXPLANTED AND REPLACED. IT WAS LATER REPORTED THAT THE HIGH THRESHOLD CONTINUED AND THE LEAD WAS LATER REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    50890 RELIA S PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ MEDTRONIC SINGAPORE OPERATIONS RES01

    Patients

    Seq Age Sex Outcome Treatment
    1 00003 YR Hospitalization| R 5071 IMPLANTABLE PACING LEAD