BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3201585 · Received July 2, 2013

    Report

    Report Number
    3007566237-2013-01062
    Event Type
    Injury
    Date Received
    July 2, 2013
    Date of Event
    August 24, 2011
    Report Date
    January 30, 2012
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCT: PRODUCT ID 8731, SERIAL # (B)(4), IMPLANTED: (B)(6) 2005, PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED DISCOMFORT AT THE RIGHT UPPER BUTTOCK POCKET SITE (B)(6) 2011. THE ELECTIVE REPLACEMENT INDICATOR (ERI) WAS 7 MONTH (B)(6) 2011. THE PUMP WAS REPLACED (B)(6) 2012 DUE TO END OF BATTERY LIFE. AT THIS TIME THE DEVICE POCKET SITE WAS REPOSITIONED TO THE ABDOMEN TO ADDRESS THE DISCOMFORT ISSUE. THE PATIENT RECOVERED WITHOUT SEQUELAE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303219 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00050 YR