BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIGMA 300 DR

    MDR report key: 2811863 · Received October 31, 2012

    Report

    Report Number
    2647346-2012-01773
    Event Type
    Injury
    Date Received
    October 31, 2012
    Report Date
    November 19, 2012
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    DXY
    PMA / PMN Number
    P980035/S2
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY (B)(4) THE DEVICE WAS RETURNED AND ANALYZED. ANALYSIS OF THE DEVICE REVEALED NORMAL BATTERY DEPLETION. (B)(6). (B)(4).

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED HEART BLOCK WHEN THE IMPLANTABLE PULSE GENERATOR (IPG) HAD COMPLETE BATTERY EXHAUSTION AND THERE WAS NO PACING AND NO TELEMETRY. THE PHYSICIAN PLACED A TEMPORARY PACEMAKER AND THE DEVICE WAS SUBSEQUENTLY 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 SIGMA 300 DR PULSE GENERATOR, PERMANENT, IMPLANTABLE DXY MEDTRONIC MED REL, INC. SDR303

    Patients

    Seq Age Sex Outcome Treatment
    1 91 YR Hospitalization| R 4068 X2 IMPLANTABLE PACING LEADS