BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIGMA 300 DR

    MDR report key: 1952513 · Received January 7, 2011

    Report

    Report Number
    6000144-2010-06787
    Event Type
    Injury
    Date Received
    January 7, 2011
    Date of Event
    October 29, 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
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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. ANALYSIS OF THE DEVICE IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CORRECTED DATA: NUMBER OF DEVICES INVOLVED CHANGED FROM ONE TO TWO, ADDED REPORTABLE LEAD TO DEVICE INFORMATION. EVALUATION SUMMARY: (B)(4): THE DEVICE WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS LIGHT HEADED DURING TRANS-TELEPHONIC MONITORING. ADDITIONALLY, WHEN THE MAGNET WAS PLACED OVER THE DEVICE, THE DEVICE LOST CAPTURE. IT WAS FURTHER REPORTED THAT THE PATIENT WAS PACEMAKER DEPENDENT AND LIKELY HAD EXIT BLOCK DUE TO A TISSUE ISSUE WHICH LED TO UNACCEPTABLY HIGH PACING THRESHOLDS. THE DEVICE WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS LIGHT HEADED DURING TRANS-TELEPHONIC MONITORING. ADDITIONALLY, WHEN THE MAGNET WAS PLACED OVER THE DEVICE, THE DEVICE LOST CAPTURE. IT WAS FURTHER REPORTED THAT THE PATIENT WAS PACEMAKER DEPENDENT AND LIKELY HAD EXIT BLOCK DUE TO A TISSUE ISSUE WHICH LED TO UNACCEPTABLY HIGH PACING THRESHOLDS FOR THE VENTRICULAR LEAD. THE DEVICE WAS ELECTIVELY EXPLANTED AND REPLACED. THE LEAD WAS CAPPED AND REPLACED. NO FURTHER 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 85 YR Hospitalization| L| R (B)(4) IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PACING LEAD