BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIGMA 300 SR

    MDR report key: 1862482 · Received October 8, 2010

    Report

    Report Number
    6000094-2010-01848
    Event Type
    Injury
    Date Received
    October 8, 2010
    Manufacturer
    MEDTRONIC S.A.
    Product Code
    DXY
    PMA / PMN Number
    P980035/S2
    Removal / Correction Number
    Z-1510/1519-2009
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    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. THIS EVENT OCCURRED OUTSIDE THE US. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. EVALUATION SUMMARY: (B)(4) PRELIMINARY TESTING REVEALED NO PACING OUTPUT WHEN DEVICE PROGRAMMED VVI 65. FURTHER TESTING REVEALED AN ANOMALOUS OUTPUT CONDITION. THE NO OUTPUT CONDITION WAS THE RESULT OF LIFTED HYBRID BOND WIRES. IT CANNOT BE DETERMINED IF THE WIRE BOND LIFTS OCCURRED BEFORE OR AFTER DEVICE EXPLANT.

    Description of Event or Problem · 1

    THE DEVICE TESTED OUT OF SPECIFICATION DURING MANUFACTURER'S ANALYSIS. THE DEVICE WAS RETURNED FROM OUTSIDE OF THE US WITHOUT INFORMATION REGARDING PATIENT IMPACT OR PRODUCT PERFORMANCE. EFFORTS TO CONTACT THE PHYSICIAN/HOSPITAL REGARDING THIS EVENT ARE IN PROCESS AT THIS TIME. FOLLOW-UP DID NOT YIELD ANY ADDITIONAL RELEVANT INFORMATION REGARDING THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIGMA 300 SR IMPLANTABLE PULSE GENERATOR DXY MEDTRONIC S.A. SSR303 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Other