BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSYNC III

    MDR report key: 1926519 · Received December 14, 2010

    Report

    Report Number
    6000094-2010-02329
    Event Type
    Injury
    Date Received
    December 14, 2010
    Manufacturer
    MEDTRONIC S.A.
    Product Code
    DXY
    PMA / PMN Number
    P010015/S005
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, 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: (B)(4): THE EXACT CAUSE OF THE ANOMALOUS LEAD IMPEDANCE READING IS UNDER INVESTIGATION AND ADDRESSED WITH A PERFORMANCE INVESTIGATION. BATTERY DEPLETION APPEARED TO BE NORMAL.

    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): ANALYSIS OF THE DEVICE REVEALED NORMAL BATTERY DEPLETION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT EXPERIENCED DIAPHRAGMATIC STIMULATION FROM THE LEFT VENTRICULAR LEAD (4193). THE LEAD WAS CAPPED AND REPLACED. IT WAS ALSO REPORTED THAT THERE WAS LOW IMPEDANCE OF 24 OHMS ON THE RIGHT VENTRICULAR LEAD (4076). THE LEAD REMAINS IN USE. IT WAS ALSO REPORTED THAT THERE WAS HIGH IMPEDANCE OF OVER 34,000 OHMS ON THE RIGHT ATRIAL LEAD (5076). THE LEAD WAS EXPLANTED AND REPLACED. IT WAS ALSO REPORTED THAT THE DEVICE EXPERIENCED A POLARITY SWITCH AND "OUT OF RANGE MEASUREMENTS." IT HAD BEEN PREVIOUSLY REPORTED THAT THE DEVICE WAS REPLACED DUE TO ERI (ELECTIVE REPLACEMENT INDICATOR). THE DEVICE WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE DEVICE WAS EXPLANTED DUE TO "OUT OF RANGE" IMPEDANCE NOT ERI.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT EXPERIENCED DIAPHRAGMATIC STIMULATION FROM THE LEFT VENTRICULAR LEAD (B)(4). THE LEAD WAS CAPPED AND REPLACED. IT WAS ALSO REPORTED THAT THERE WAS LOW IMPEDANCE OF 24 OHMS ON THE RIGHT VENTRICULAR LEAD (B)(4). THE LEAD REMAINS IN USE. IT WAS ALSO REPORTED THAT THERE WAS HIGH IMPEDANCE OF OVER 34,000 OHMS ON THE RIGHT ATRIAL LEAD (B)(4). THE LEAD WAS EXPLANTED AND REPLACED. IT WAS ALSO REPORTED THAT THE DEVICE EXPERIENCED A POLARITY SWITCH AND "OUT OF RANGE MEASUREMENTS." IT HAD BEEN PREVIOUSLY REPORTED THAT THE DEVICE WAS REPLACED DUE TO ERI (ELECTIVE REPLACEMENT INDICATOR). THE DEVICE WAS EXPLANTED AND REPLACED. 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 70 YR Hospitalization| O| R