BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIGMA 300 VDD

    MDR report key: 1925316 · Received December 14, 2010

    Report

    Report Number
    2647346-2010-00868
    Event Type
    Injury
    Date Received
    December 14, 2010
    Date of Event
    September 27, 2010
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    DXY
    PMA / PMN Number
    P980035/S2
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION SUMMARY: (B)(4) ANALYSIS OF THE DEVICE REVEALED NORMAL BATTERY DEPLETION.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. ANALYSIS OF THE DEVICE IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE TO PLACE AN ATRIAL LEAD, THERE WAS SOME OVERSENSING/SENSING DIFFICULTY, LOSS OF CAPTURE AND NO PACING OUTPUT. THE LEAD CHECKED OUT AS OKAY ON THE ANALYZER. THE PACEMAKER WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    ASKU

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIGMA 300 VDD IMPLANTABLE PULSE GENERATOR DXY MEDTRONIC MED REL, INC. SVDD303 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention 5038 IMPLANTABLE PACING LEAD| 5038 IMPLANTABLE PACING LEAD