BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIGMA 300 DR

    MDR report key: 1991083 · Received February 15, 2011

    Report

    Report Number
    6000144-2011-00827
    Event Type
    Injury
    Date Received
    February 15, 2011
    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
    MI, 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): NO ANOMALIES FOUND. A RIBBON CABLE WAS BROKEN.

    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 THE PATIENT WENT INTO ASYSTOLE. THE DEVICE WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WENT INTO TO ASYSTOLE. THE DEVICE WAS 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 IMPLANTABLE PULSE GENERATOR DXY MEDTRONIC MED REL, INC. SDR303 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization| L| R 5076 IMPLANTABLE PACING LEAD| 5568 IMPLANTABLE PACING LEAD| 5568 IMPLANTABLE PACING LEAD| 5076 IMPLANTABLE PACING LEAD