BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G SERIES DR

    MDR report key: 3153081 · Received June 8, 2013

    Report

    Report Number
    3002807576-2013-00013
    Event Type
    Injury
    Date Received
    June 8, 2013
    Date of Event
    March 18, 2013
    Report Date
    March 19, 2013
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    DXY
    PMA / PMN Number
    P990001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HU
    Reporter Occupation
    OTHER

    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. THE DEVICE WAS RETURNED AND ANALYZED. NO ANOMALIES WERE FOUND. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) WAS "INEFFECTIVE". THE PHYSICIAN REPORTED THE PATIENT RETURNED WITH A LOW INTRINSIC RATE AND FELT DIZZINESS. THE DEVICE WAS REMOVED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    256165 G SERIES DR PULSE-GENERATOR, PACEMAKER, IMPLANTABLE DXY IPG MFG SWITZERLAND G70A1

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R