BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANTED DRUG INFUSION PUMP

    MDR report key: 7573924 · Received June 6, 2018

    Report

    Report Number
    3007566237-2018-01708
    Event Type
    Injury
    Date Received
    June 6, 2018
    Date of Event
    March 1, 2018
    Report Date
    June 6, 2018
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P8760004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    BUXTON K, DIFAZIO R, MORGAN A, MCCABE M, FORBES PW. INTRATHECAL BACLOFEN THERAPY PRIOR TO SPINAL FUSION FOR PATIENTS WITH GROSS MOTOR FUNCTION CLASSIFICATION SYSTEM IV-V CEREBRAL PALSY. ORTHOP NURS. 2018;37(2):136-143.DOI: 10.1097/NOR.0000000000000434. PLEASE NOTE THAT THIS DATE IS BASED OFF THE DATE OF PUBLICATION AS THE ACTUAL EVENT DATE WAS NOT PROVIDED. IT WAS NOT POSSIBLE TO MATCH THIS EVENT WITH ANY PREVIOUSLY REPORTED EVENT. CONTINUATION OF MEDICAL DEVICES: PRODUCT ID NEU_UNKNOWN_CATH, PRODUCT TYPE CATHETER. INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: NEU_UNKNOWN_CATH. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED. (B)(4).

    Description of Event or Problem · 1

    SUMMARY: THIS STUDY SOUGHT TO COMPARE POSTOPERATIVE RECOVERY FOLLOWING SPINAL FUSION IN PATIENTS USING ITB THERAPY WITH THOSE WITH NO ITB THERAPY. REPORTED EVENTS: ONE PATIENT WITH AN ITB PUMP EXPERIENCED WITHDRAWAL RELATED TO CATHETER DISRUPTION AND RETURNED TO THE OPERATING ROOM FOR REPAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    415993 IMPLANTED DRUG INFUSION PUMP PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION NEU_UNKNOWN_PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention