BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CATHETER

    MDR report key: 5361138 · Received January 12, 2016

    Report

    Report Number
    3007566237-2016-00221
    Event Type
    Injury
    Date Received
    January 12, 2016
    Report Date
    December 22, 2015
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ON 2015-12-22 INFORMATION WAS RECEIVED FROM A HEALTH CARE PROFESSIONAL VIA A REPRESENTATIVE THAT THIS PATIENT HAD A CATHETER REVISION IN 2006. THE PATIENT'S DIAGNOSIS INCLUDED BILATERAL SEVERE DYSKINETIC CEREBRAL PALSY BASED ON PREMATURITY AND STATUS AFTER INFANT RESPIRATORY DISTRESS SYNDROME (IRDS) GRADE 3 AND SEPSIS. THE PATIENT'S MEDICAL HISTORY INCLUDED THE FIRST PUMP RECEIVED ON (B)(6) 2005. IN 2011, A DRAIN DISCONNECTION AND A NEW BACLOFEN PUMP AND RECONNECTION DRAIN ON (B)(6) 2011. THE NEW BACLOFEN PUMP WAS FOR A REGULAR REPLACEMENT OF THE PUMP, ALMOST END OF LIFE. THERE WERE NO KNOWN ALLERGIES. NO FURTHER INFORMATION WAS PROVIDED AT THE TIME OF THE INITIAL REPORT. THE MODEL AND SERIAL OF THE CATHETER, PATIENT SYMPTOMS, DIAGNOSTIC TESTING AND TROUBLESHOOTING, CONTEXT OF THE EVENT, REASON/CAUSE OF THE REVISION, EVENT DATE, THE MEDICATION TYPE, CONCENTRATION, LOT NUMBER, AND DOSE DELIVERED AT THE TIME OF THE EVENT WERE NOT PROVIDED. ALL OF THESE WERE REQUESTED AS WELL AS CLARIFICATION OF THE REPORTED "DRAIN". SHOULD ADDITIONAL INFORMATION BE RECEIVED A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE MANUFACTURER REPRESENTATIVE INDICATING THAT A RE-CONNECTION OF THE ABDOMINAL SEGMENT OF THE CATHETER DUE TO A CATHETER KINK TOOK PLACE (B)(6) 2006. THE TYPE OF CATHETER, MODEL, AND SERIAL NUMBER COULD NOT BE OBTAINED. NO FURTHER INFORMATION WAS ABLE TO BE OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    19592 CATHETER PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION NEU_UNKNOWN_CATH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention