BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1850831 · Received September 28, 2010

    Report

    Report Number
    3004209178-2010-07371
    Event Type
    Injury
    Date Received
    September 28, 2010
    Date of Event
    September 1, 2010
    Report Date
    March 8, 2018
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE DEVICE HAS BEEN RETURNED TO THE MFR FOR ANALYSIS WHICH IS NOT COMPLETE AS OF THE DATE OF THIS REPORT. A F/U REPORT WILL BE SENT WHEN THE ANALYSIS IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD NO PAIN RELIEF SINCE BEING IMPLANTED. A CATHETER DYE STUDY WAS ATTEMPTED. IT WAS NOT POSSIBLE TO ASPIRATE FROM THE PT'S CATHETER. THE CATHETER WAS REMOVED AND REPLACED. THERE WERE NO OBVIOUS KINKS IN THE CATHETER NOTED. THE MEDICATION USED IN THE PT'S PUMP WAS DILAUDID AT A CONCENTRATION OF 0.2 MG/ML AND A DOSAGE OF 0.02 MG/DAY. THE PT RECOVERED WITHOUT SEQUELA. NO FURTHER DETAILS WERE PROVIDED AT THE TIME OF THIS REPORT. A F/U REPORT WILL BE FILED IF ADD'L INFO BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MDT PUERTO RICO OPERATIONS CO., JUNCOS 8637-20 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Female Required Intervention CATHETER: MODEL 8709SC, LOT# N256563005.| EXPLANTED:| EXPLANTED: | IMPLANTED:| IMPLANTED: | PROGRAMMER: MODEL 8835, LOT# NPG018041N.| PROGRAMMER: MODEL 8835, LOT# NPG018041N| EXPLANTED:| IMPLANTED:| IMPLANTED:| CATHETER: MODEL 8709SC, LOT# N256563005| EXPLANTED: