BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIGMA 300 DR

    MDR report key: 1072546 · Received July 10, 2008

    Report

    Report Number
    6000144-2008-00183
    Event Type
    Malfunction
    Date Received
    July 10, 2008
    Date of Event
    April 24, 2008
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    DXY
    PMA / PMN Number
    ASKU
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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: DISTAL CONDUCTOR FRACTURED; FULL LEAD RETURNED AND ANALYZED; DISTAL CONDUCTOR FRACTURED; FULL LEAD RETURNED AND ANALYZED. PRELIMINARY ANALYSIS FOUND A NO OUTPUT CONDITION. ADDITIONAL TESTING DETERMINED THIS WAS DUE TO LIFTED HYBRID BOND WIRES. IT WAS REPORTED THAT LOSS OF CAPTURE WAS NOTED AS WELL AS NOISE ON THE LEADS. THE PATIENT HAD A SEIZURE AND A TEMPORARY PACEMAKER WAS PLACED. IT WAS FURTHER REPORTED THAT THE PATIENT HAD PRE-SYNCOPE FOR ONE WEEK PRIOR TO SYSTEM REPLACEMENT. THE IPG AND BOTH LEADS WERE EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S STATUS WAS REPORTED AS "WELL". THE ATRIAL LEAD WAS RETURNED TO THE MANUFACTURER, ANALYZED, AND TESTED OUT OF SPECIFICATION. ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED. ELECTRICAL TESTS PERFORMED; MECHANICAL TESTS PERFORMED. VISUAL EXAMINATION: WIRE, COMPONENT/SUBASSEMBLY FAILURE. DEVICE WAS OUT OF SPECIFICATION IN A MANNER THAT RELATES TO EVENT, CAPTURE, FAILURE TO, OVERSENSING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT LOSS OF CAPTURE WAS NOTED AS WELL AS NOISE ON THE LEADS. THE PATIENT HAD A SEIZURE AND A TEMPORARY PACEMAKER WAS PLACED. IT WAS FURTHER REPORTED THAT THE PATIENT HAD PRE-SYNCOPE FOR ONE WEEK PRIOR TO SYSTEM REPLACEMENT. THE IPG AND BOTH LEADS WERE EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S STATUS WAS REPORTED AS "WELL". THE ATRIAL LEAD WAS RETURNED TO THE MANUFACTURER, ANALYZED, AND TESTED OUT OF SPECIFICATION.

    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 Required Intervention 5076 IMPLANTABLE PACING LEAD