BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3191282 · Received June 26, 2013

    Report

    Report Number
    3007566237-2013-02119
    Event Type
    Injury
    Date Received
    June 26, 2013
    Report Date
    June 18, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THAT THE SECOND CATHETER FRACTURE WAS FOUND BECAUSE THE PATIENT HAD A DECREASE IN PAIN CONTROL. A DYE STUDY SHOWED SOME LEAKAGE INTO THE SPINE, NOT AT THE CATHETER TIP. PRIOR TO THE REPLACEMENT, THE DEVICE SYSTEM WAS USED TO DELIVER MORPHINE 25MG/ML AT 2MG/DAY. SINCE THE REPLACEMENT, THE PATIENT HAD GOOD THERAPY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CATHETER FRACTURED AND THE CATHETER AND PUMP WERE REPLACED IN (B)(6), 2013. THE PATIENT STATED THEY REPLACED THE PUMP DURING THE CATHETER SURGERY SINCE THE PUMP HAD APPROXIMATELY ONE YEAR LEFT OF BATTERY LIFE, THUS REPLACED THEM BOTH AT THAT TIME. THE DRUG IN THE PUMP AT THE TIME OF THE EVENT WAS NOT SPECIFIED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    289955 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 863740

    Patients

    Seq Age Sex Outcome Treatment
    1 00066 YR Required Intervention