BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSYNC III

    MDR report key: 1926538 · Received December 14, 2010

    Report

    Report Number
    6000094-2010-02331
    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
    Report Source
    Manufacturer report
    Reporter Location
    MO, 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) NO ANOMALIES WERE FOUND; THE FULL LEAD WAS RETURNED AND ANALYZED. ALL CONDUCTORS HAD BLOOD/BODY FLUID (NOT OBSTRUCTED). (B)(4) NO ANOMALIES FOUND. ALL CONDUCTORS HAD BLOOD/BODY FLUID (NOT OBSTRUCTED); OUTER INSULATION MELTED AND COSMETIC ENVIRONMENTAL STRESS CRACKING. APPARENT EXPLANT DAMAGE. THE PROXIMAL SEGMENT OF THE LEAD WAS RETURNED AND ANALYZED. (B)(4) NO ANOMALIES FOUND. OUTER INSULATION MELTED AND COSMETIC ENVIRONMENTAL STRESS CRACKING. APPARENT EXPLANT DAMAGE. THE PROXIMAL SEGMENT OF THE LEAD WAS RETURNED AND ANALYZED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SYSTEM WAS REMOVED DUE TO HEMATOMA AND INFECTION. THE DEVICE IS BEING USED AS AN EXTERNAL PACER UNTIL THE INFECTION CLEARS AND A NEW SYSTEM CAN BE IMPLANTED. NO FURTHER PATIENT COMPLICATIONS WERE 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 49 YR Hospitalization| R