BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSYNC III

    MDR report key: 1792553 · Received August 11, 2010

    Report

    Report Number
    6000094-2010-01467
    Event Type
    Injury
    Date Received
    August 11, 2010
    Date of Event
    April 12, 2010
    Manufacturer
    MEDTRONIC S.A.
    Product Code
    DXY
    PMA / PMN Number
    P010015/S005
    Removal / Correction Number
    ASKU
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 TESTING REVEALED A NO OUTPUT CONDITION WHEN DEVICE WAS PROGRAMMED VVI 60 BIPOLAR. ATS TESTING REVEALED ANOMALOUS OUTPUT CONDITIONS. THE NO OUTPUT CONDITION WAS THE RESULT OF LIFTED HYBRID BOND WIRES EXPLANT. ANALYSIS OF THE AUTOMATIC LEAD DIAGNOSTIC DATA REVEALED THE RIGHT AND LEFT VENTRICULAR LEADS MEASURED AN OPEN ON (B)(6) 2010 WHICH COINCIDES WITH THE EXPLANT DATE.

    Description of Event or Problem · 1

    THE DEVICE WAS REPLACED DUE TO ERI (ELECTIVE REPLACEMENT INDICATOR). THE DEVICE WAS RETURNED TO THE MANUFACTURER, ANALYZED, AND TESTED OUT OF SPECIFICATION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSYNC III IMPLANTABLE PULSE GENERATOR DXY MEDTRONIC S.A. 8042 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other 4461 COMPETITOR IMPLANTABLE PACING LEAD| 2187 IMPLANTABLE PACING LEAD| 4285 COMPETITOR IMPLANTABLE PACING LEAD