BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3013262 · Received March 20, 2013

    Report

    Report Number
    3007566237-2013-00843
    Event Type
    Injury
    Date Received
    March 20, 2013
    Date of Event
    June 15, 2012
    Report Date
    March 14, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL DEVICE: CATHETER MODEL: UNK, SERIAL/LOT#: UNK. THE ACTUAL EVENT DATE WAS NOT PROVIDED; THIS DATE IS BASED ON THE DATE OF PUBLICATION OF THE ABSTRACT. IT WAS NOT POSSIBLE TO MATCH THIS EVENT WITH ANY PREVIOUSLY REPORTED EVENTS. (B)(4).

    Description of Event or Problem · 1

    WIEST, T., MUNSON, R., GEIS, T., KUMAR, K. INTRATHECAL PUMP POCKET REFILLS: A POTENTIAL COMPLICATION, AND THE RESULTING CHANGES IN THE REGINA NEUROMODULATION CLINIC. NEUROMODULATION. 2012;15(6):E8. DOI: 10.1111/J.1525-1403.2012.00533.X. SUMMARY/REPORTED EVENT FOR PATIENT (B)(6): PATIENT (B)(6) WAS IMPLANTED FOR CHRONIC SPASTICITY SECONDARY TO CEREBRAL PALSY AND IS RECEIVING BACLOFEN. PUMP POCKET REFILLS WERE DISCOVERED SHORTLY AFTER BOTH REFILL PROCEDURES. PATIENTS WERE ADMITTED TO HOSPITAL FOR OBSERVATION AND TREATMENT POST INCIDENT, AND DISCHARGED WITHIN 48 HOURS, WITH NO DELETERIOUS EFFECTS. DUE TO THESE INCIDENTS, CHANGES HAVE BEEN IMPLEMENTED IN POLICY, PROCEDURES AND NURSING PRACTICE WITHIN (B)(6). THESE INCLUDE CONSENTS FOR POTENTIAL OFF LABEL MEDICATION USE, IMPLEMENTATION OF A 30 MINUTE POST REFILL OBSERVATION PERIOD AND CHANGES TO OUR REFILL PROCEDURE IN AN EFFORT TO MINIMIZE NEEDLE DISPLACEMENT DURING PUMP REFILL. ADDITIONAL INFORMATION IS BEING REQUESTED AT THIS TIME; A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    115654 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 8637

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R