BEUDAMED
    FDA Adverse Event Summary report: N

    SIGMA 300 DR

    MDR report key: 1862462 · Received October 8, 2010

    Report

    Report Number
    6000144-2010-04709
    Date Received
    October 8, 2010
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    DXY
    PMA / PMN Number
    P980035/S2
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BASED SOLELY ON DEVICE RETURN AND ANALYSIS. NO INFORMATION TO SUGGEST A DEVICE-RELATED ADVERSE EVENT OR PRODUCT PROBLEM WAS RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION SUMMARY: (B)(4) PRELIMINARY ANALYSIS REVEALED NO OUTPUT AND NO TELEMETRY. FURTHER TESTING REVEALED THAT THE NO OUTPUT AND NO TELEMETRY CONDITIONS WERE THE RESULT OF LIFTED HYBRID BOND WIRES.

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BASED SOLELY ON DEVICE RETURN AND ANALYSIS. NO INFORMATION TO SUGGEST A DEVICE-RELATED ADVERSE EVENT OR PRODUCT PROBLEM WAS RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION SUMMARY: (B)(4) PRELIMINARY TESTING REVEALED NO PACING OUTPUT WHEN DEVICE WAS PROGRAMMED OVO MODE. THE NO OUTPUT CONDITION WAS THE RESULT OF LIFTED HYBRID BOND WIRES. ANALYSIS OF THE DEVICE MEMORY DATA REVEALED THE DEVICE LEAD IMPEDANCE MEASURED OK AS OF THE DATE OF EXPLANT. CORRECTION: REVISED EVENT DESCRIPTION AND DEVICE CONCLUSION.

    Description of Event or Problem · 1

    THE DEVICE WAS RETURNED TO THE MANUFACTURER, ANALYZED AND SUBSEQUENTLY TESTED OUT OF SPECIFICATION. THE DEVICE WAS RETURNED WITHOUT INFORMATION REGARDING PATIENT IMPACT OR PRODUCT PERFORMANCE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    THE DEVICE WAS RETURNED TO THE MANUFACTURER, ANALYZED AND INITIAL ANALYSIS INDICATED THAT IT WAS OUT OF SPECIFICATION. FURTHER INFORMATION OBTAINED FROM THE PHYSICIAN'S OFFICE INDICATED THERE WERE NO REPORTED ISSUES WITH THIS DEVICE. DEVICE MEMORY DATA FROM THE DEVICE SHOWED THE DEVICE WAS OPERATING CORRECTLY. IT IS THEREFORE CONCLUDED THAT THE LOOSE/DETACHED WIREBONDS FOUND IN THE DEVICE OCCURRED AFTER PATIENT USE. 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 ASKU DXY MEDTRONIC MED REL, INC. SDR303 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention COMPETITIOR IMPLANTABLE PACING LEAD| COMPETITIOR IMPLANTABLE PACING LEAD| COMPETITOR IMPLANTABLE PACING LEAD| COMPETITOR IMPLANTABLE PACING LEAD