BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1842044 · Received September 21, 2010

    Report

    Report Number
    3007566237-2010-07158
    Event Type
    Injury
    Date Received
    September 21, 2010
    Date of Event
    August 30, 2010
    Report Date
    August 30, 2010
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A ROUTINE SCHEDULED PUMP REPLACEMENT SURGERY, THE PHYSICIAN WAS UNABLE TO GET CEREBROSPINAL FLUID (CSF) BACK FROM THE CATHETER AFTER DISCONNECTING THE OLD PUMP FROM THE CATHETER. UNDER FLUOROSCOPY, IT WAS NOTICED THAT THERE WAS AN ABRUPT END TO THE EXISTING CATHETER WHERE IT SHOULD HAVE ENTERED INTO THE INTRATHECAL (IT) SPACE. A PIECE OF CATHETER, FREE-FLOATING IN THE CSF WAS ALSO SEEN. THE CATHETER FRACTURE WAS CONFIRMED WHEN THE PT'S BACK WAS OPENED TO EXAMINE THE CATHETER. THE OLD CATHETER (EXCEPT FOR THE PORTION IN THE CSF) WAS EXPLANTED AND A NEW CATHETER WAS IMPLANTED. THE NEW CATHETER HAD "GREAT CSF FLOW." THE MEDICATION USED IN THE PT'S PUMP WAS LIORESAL AT A CONCENTRATION OF 2,000 MCG/ML. IT WAS NOTED THAT THE PT'S PREVIOUS PUMP MEDICATION DOSE WAS 300 MCG/DAY. DUE TO THE CATHETER FRACTURE, THE DOSAGE WAS DECREASED TO 100 MCG/DAY. THE PT WAS ADMITTED TO THE HOSPITAL FOLLOWING THE SURGERY. ON (B)(6) 2010, THE PT WAS NOTED TO BE "DROWSY." THE PUMP MEDICATION DOSAGE WAS THEN DECREASED TO THE MINIMUM RATE OF 12 MCG/DAY. ON (B)(6) 2010, THE PT WAS STILL ADMITTED TO THE HOSPITAL. THE PT WAS SITTING UP AND "DOING WELL." THE PT'S PUMP MEDICATION DOSAGE WAS INCREASED TO 96 MCG/DAY. LATER THAT DAY, THE PT WAS "WALKING AND FEELING GOOD." THE PT WAS TO BE TRANSFERRED TO A REHAB HOSPITAL FOR FURTHER TREATMENT AND EVAL. 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 MEDTRONIC NEUROMODULATION 863720 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Hospitalization| R CATHETER: MODEL 8709, LOT #: J11893R27| EXPLANTED:| IMPLANTED: