BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN

    MDR report key: 2032524 · Received March 24, 2011

    Report

    Report Number
    3007566237-2011-02283
    Event Type
    Injury
    Date Received
    March 24, 2011
    Date of Event
    February 14, 2011
    Report Date
    February 14, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): ANALYSIS RESULTS OF THE RETURNED CATHETER WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A F/U REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED. THIS REPORT IS BEING SUBMITTED LATE DUE TO A DELAY BY A MANUFACTURER EMPLOYEE. A PROCESS IMPROVEMENT PLAN AND TRAINING ARE IN PLACE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT'S THERAPY "APPEARED INEFFECTIVE." UPON INVESTIGATION, DURING SURGICAL INTERVENTION, THE CATHETER WAS NOTED TO BE FRACTURED. THE CATHETER WAS REPLACED; "CORRECTIVE SURGERY COMPLETED." THE PUMP CONTAINED BACLOFEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN UNK LKK MEDTRONIC NEUROMODULATION PUMP NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention CATHETER: MODEL 8709, LOT # UNK| EXPLANTED:| IMPLANTED: