BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSYNC III

    MDR report key: 2050755 · Received April 12, 2011

    Report

    Report Number
    6000144-2011-01480
    Event Type
    Malfunction
    Date Received
    April 12, 2011
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    DXY
    PMA / PMN Number
    P010015/S005
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD COMPLAINT OF A BURNING SENSATION AT PACEMAKER SITE THAT IMPROVES WITH MASSAGE. THE PATIENT WILL SCHEDULE APPOINTMENT WITH PHYSICIAN. THE DEVICE IS STILL IN USE. 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 MED REL, INC. 8042 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Other 4193 IMPLANTABLE PACING LEAD| 5076 IMPLANTABLE PACING LEAD