BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIGMA 300 DR

    MDR report key: 2123125 · Received June 14, 2011

    Report

    Report Number
    6000094-2011-00707
    Event Type
    Injury
    Date Received
    June 14, 2011
    Manufacturer
    MEDTRONIC S.A.
    Product Code
    DXY
    PMA / PMN Number
    P980035/S2
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE CAPSULE "BECAME VERY THIN." THE PHYSICIAN PERFORMED "SURGERY TO CHECK, FOUND NO CONNECTIVE TISSUE AROUND THE DEVICE," AND THAT "THE CONNECTION PART OF [THE] LEADS AND IPG (PACEMAKER) [WERE] OUTSIDE OF THE MUSCLE." THE IPG AND BOTH LEADS REMAIN IN USE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIGMA 300 DR IMPLANTABLE PULSE GENERATOR DXY MEDTRONIC S.A. SDR303 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R