BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

    MDR report key: 2580233 · Received May 18, 2012

    Report

    Report Number
    3007566237-2012-01121
    Event Type
    Injury
    Date Received
    May 18, 2012
    Date of Event
    March 11, 2005
    Report Date
    April 23, 2012
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CATHETER MODEL 870953 SERIAL# (B)(4) IMPLANTED: (B)(6) 2001 EXPLANTED: UNK. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THAT THE CAUSE OF THE CATHETER DISCONNECTION WAS UNKNOWN. THE LOCATION OF THE DISCONNECTION WAS AT THE METAL CONNECTOR SITE. THEIR SUSPICION WAS THAT THE INCREASE IN PAIN, SWEATING, AND NAUSEA WERE RELATED TO THE DISCONNECTION AS THE PATIENT ALWAYS PRESENTED THE SAME WAY WITH THOSE SYMPTOMS. THERE WERE NO OTHER SYMPTOMS RELATED TO THE DISCONNECTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED WITH A SHARP INCREASE IN PAIN ALONG WITH SWEATING AND NAUSEA. THE PATIENT UNDERWENT SURGERY; THE CATHETER WAS RECONNECTED. THE PUMP CONTAINED DILAUDID. A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention