BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1242963 · Received November 21, 2008

    Report

    Report Number
    3004209178-2008-07675
    Event Type
    Injury
    Date Received
    November 21, 2008
    Date of Event
    October 1, 2008
    Report Date
    October 28, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER DOING A LOAD OF LAUNDRY, THE PATIENT FELT A BURNING SENSATION AROUND THE PUMP AREA. THE PATIENT ALSO NOTICED AN INCREASE IN PAIN AND THAT THE PUMP DID NOT "CONTROL THE PAIN LIKE IS USED TO". THE PATIENT ADDITIONALLY REPORTED FEELING "SLEEPY". THE HCP ORIGINALLY SUSPECTED THE PATIENT HAD "STRETCHED A NERVE". THE PATIENT FELT THE PUMP FLIP AND WAS CONFIRMED BY THE HCP. THE PATIENT WAS SCHEDULED FOR A PUMP POCKET REVISION AT THE NEXT REFILL DATE, 2008. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 8637-40 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention CATHETER MODEL 8709SC| EXPLANTED| PROGRAMMER MODEL 8840