BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_PUMP

    MDR report key: 4130046 · Received September 30, 2014

    Report

    Report Number
    3007566237-2014-02783
    Event Type
    Injury
    Date Received
    September 30, 2014
    Date of Event
    September 26, 2012
    Report Date
    September 8, 2014
    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
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID NEU_UNKNOWN_CATH, SERIAL# UNKNOWN, IMPLANTED: (B)(6) 2012, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL REVIEW INDICATES THE INFORMATION PREVIOUSLY REPORTED UNDER THIS MANUFACTURER REPORT # PERTAINS TO MANUFACTURER REPORT # 3004209178-2013-00283. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THE INFORMATION RECEIVED WILL BE REPORTED UNDER THIS MANUFACTURER REPORT # 3004209178-2013-00283.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2012, THE PATIENT HAD A PAIN PUMP AND SPINAL CATHETER IMPLANTED TO PROVIDE RELIEF FROM INTRACTABLE SPINAL PAIN. ON OR ABOUT (B)(6) 2012 THE CATHETER MALFUNCTIONED ¿ON INFORMATION AND BELIEF¿ FROM A MANUFACTURING DEFECT. THE CATHETER DID NOT TRANSMIT PAIN RELIEVING MEDICATION FROM THE PUMP TO THE PATIENT¿S INTRATHECAL SPACE. THE CATHETER HAD BROKEN AND FAILED TO DELIVER ANALGESICS TO THE PATIENT¿S INTRATHECAL AREA WHICH NECESSITATED SURGICAL REMOVAL, AND CAUSED THE PATIENT TO SUFFER PERMANENT AND PERMANENTLY DISABLING INJURIES. THE CATHETER WAS EXPLANTED ON (B)(6) 2012. THE PATIENT CONTINUED TO EXPERIENCE GREAT PAIN AND MENTAL ANGUISH AS WELL AS LOSS OF NORMAL LIFE. THE MEDICATION DELIVERED BY THE DEVICE SYSTEM WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    608806 UNKNOWN_PUMP PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION UNKNOWN_PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention| S