BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RELIA DR

    MDR report key: 3153605 · Received June 8, 2013

    Report

    Report Number
    3008973940-2013-00070
    Event Type
    Injury
    Date Received
    June 8, 2013
    Date of Event
    March 22, 2013
    Report Date
    March 26, 2013
    Manufacturer
    MEDTRONIC SINGAPORE OPERATIONS
    Product Code
    NVZ
    PMA / PMN Number
    P980035
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED AND ANALYSIS FOUND NO ANOMALIES. ANALYSIS OF THE DEVICE MEMORY WAS PERFORMED AND NO ANOMALIES WERE FOUND. (B)(4).

    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. CONTINUATION: 5076-52 IMPLANTABLE PACING LEAD 2013-(B)(6). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THREE DAYS POST IMPLANT, THE LEAD SHOWED HIGH AURICULAR IMPEDANCE IN BIPOLAR. THE LEAD WAS EXPLANTED AND REPLACED. HOWEVER, THE HIGH IMPEDANCE CONTINUED SO THE DEVICE WAS EXPLANTED AND REPLACED AS WELL. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    254145 RELIA DR PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ MEDTRONIC SINGAPORE OPERATIONS REDR01

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R