BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRAX SX

    MDR report key: 1855064 · Received October 5, 2010

    Report

    Report Number
    2647346-2010-00540
    Event Type
    Injury
    Date Received
    October 5, 2010
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    DXY
    PMA / PMN Number
    K791181/A/B
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, 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) BATTERY DEPLETION WAS FOUND TO BE NORMAL. (B)(4) PROXIMAL SEGMENT OF THE LEAD WAS RETURNED AND ANALYZED. NO ANOMALIES FOUND. THE OUTER INSULATION WAS BREACHED CUT.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. ANALYSIS OF THE DEVICE IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE. EVALUATION SUMMARY: (B)(4) PROXIMAL SEGMENT OF THE LEAD WAS RETURNED AND ANALYZED. NO ANOMALIES FOUND. THE OUTER INSULATION WAS BREACHED CUT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TELEMETRY COULD NOT BE ESTABLISHED WITH THE DEVICE. THE DEVICE WAS FOUND TO BE ERODED THROUGH THE PATIENT'S SKIN. THE PATIENT HAD BEEN WRAPPING THE DEVICE IN TISSUES FOR MORE THAN TEN YEARS IN ORDER TO AVOID AN ADDITIONAL SURGICAL PROCEDURE. THE DEVICE WAS EXPLANTED AND THE LEAD WAS CAPPED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TELEMETRY COULD NOT BE ESTABLISHED WITH THE DEVICE. THE DEVICE WAS FOUND TO BE ERODED THROUGH THE PATIENT'S SKIN. THE PATIENT HAD BEEN WRAPPING THE DEVICE IN TISSUES FOR MORE THAN TEN YEARS IN ORDER TO AVOID AN ADDITIONAL SURGICAL PROCEDURE. THE DEVICE WAS EXPLANTED AND THE LEAD WAS CAPPED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPECTRAX SX ASKU DXY MEDTRONIC MED REL, INC. 5984 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention