BEUDAMED
    FDA Adverse Event Summary report: N

    SIGMA 300 SR

    MDR report key: 1791734 · Received August 10, 2010

    Report

    Report Number
    2647346-2010-00345
    Date Received
    August 10, 2010
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    DXY
    PMA / PMN Number
    P980035/S2
    Removal / Correction Number
    Z-1510/1519-2009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    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) PRELIMINARY TESTING REVEALED NO OUTPUT WHEN DEVICE WAS PROGRAMMED VVIR 60 BPM UNIPOLAR MODE. TESTING ON THE AUTOMATED FUNCTIONAL TESTERS REVEALED ANOMALOUS OUTPUT CONDITIONS. THE NO OUTPUT CONDITION WAS THE RESULT OF LIFTED HYBRID BOND WIRES. ANALYSIS OF THE MEMORY DUMP DATA REVEALED THE DEVICE LEAD IMPEDANCE MEASURED OPEN ON (B)(6) 2009 WHICH IS THE SAME AS THE EXPLANT DATE OF (B)(6) 2009.

    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 FDA ACT. #. EVALUATION SUMMARY: (B)(4): PRELIMINARY TESTING REVEALED NO OUTPUT WHEN DEVICE WAS PROGRAMMED VVIR 60 BPM UNIPOLAR MODE. TESTING ON THE AUTOMATED FUNCTIONAL TESTERS REVEALED ANOMALOUS OUTPUT CONDITIONS. THE NO OUTPUT CONDITION WAS THE RESULT OF LIFTED HYBRID BOND WIRES. ANALYSIS OF THE MEMORY DUMP DATA REVEALED THE DEVICE LEAD IMPEDANCE MEASURED OPEN ON (B)(6)2009 WHICH IS THE SAME AS THE EXPLANT DATE OF (B)(6)2009.

    Description of Event or Problem · 1

    THE PATIENT'S WIFE REPORTED THAT THE DEVICE WAS "SHOCKING" THE PATIENT. 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

    THE PATIENT'S WIFE REPORTED THAT THE DEVICE WAS "SHOCKING" THE PATIENT. THE DEVICE WAS EXPLANTED 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 SR ASKU DXY MEDTRONIC MED REL, INC. SSR303 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention 5024M IMPLANTABLE PACING LEAD| 5024M IMPLANTABLE PACING LEAD