BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN INFUSION PUMP

    MDR report key: 4241332 · Received November 10, 2014

    Report

    Report Number
    3007566237-2014-03282
    Event Type
    Injury
    Date Received
    November 10, 2014
    Date of Event
    October 16, 2014
    Report Date
    March 17, 2015
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THAT THE PATIENT HAS BEEN ADMITTED ON (B)(6) 2014 FOR A ¿DAY CARE¿. THE HEALTH CARE PROFESSIONAL REPORTED THAT THE EVENT DID NOT REQUIRE NEITHER PUMP NOR CATHETER REVISION, BUT REPOSITIONING AND REFILL OF THE INTRATHECAL BACLOFEN PUMP AND PLACEMENT OF BACLOFEN PUMP IN A STERILE MESH POUCH.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT REQUIRED AND ADDITIONAL SURGERY. A FOLLOW-UP REPORT WILL BE SUBMITTED IF MORE INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE SUBJECT WAS COMPLETELY RECOVERED FROM THE PUMP MIGRATION. THE INVESTIGATOR ASSESSED THE PUMP MIGRATION AS SERIOUS (MEDICALLY SIGNIFICANT) REQUIRED ADDITIONAL SURGERY. THE SERIOUSNESS CRITERION WAS UPDATED AS MEDICALLY SIGNIFICANT (PREVIOUSLY REPORTED AS LIFE THREATENING, HOSPITALIZATION, AND MEDICALLY SIGNIFICANT).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED UPDATED THE EVENT TERM FROM FLIPPED BACLOFEN PUMP TO PUMP REVISION DUE TO MIGRATION OF INTRATHECAL BACLOFEN (ITB) PUMP. THE PATIENT WAS ADMITTED ON (B)(6) 2014 FOR A ¿DAY CARE¿ AND WAS DISCHARGED ON THE SAME DAY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A FLIPPED PUMP/PUMP MIGRATION OCCURRED WHICH RESULTED IN HOSPITALIZATION. HOSPITALIZATION WAS REQUIRED TO CORRECT THE FLIPPED PUMP. ON THE SAME DAY, THE SUBJECT'S INTRATHECAL STUDY MEDICATION DOSE WAS REDUCED. THE EVENT WAS REPORTED AS ¿SERIOUS (LIFE THREATENING, HOSPITALIZATION AND MEDICALLY SIGNIFICANT)¿. THE EVENT WAS RELATED TO THE PUMP POCKET AND NOT RELATED TO THE MEDICATION. THE PUMP WAS USED TO INFUSE BACLOFEN. NO OUTCOME WAS REPORTED REGARDING THIS EVENT. ADDITIONAL INFORMATION COULD NOT BE OBTAINED AT THE TIME OF THE REPORT. SHOULD ADDITIONAL BE RECEIVED A SUPPLEMENTAL REPORT WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    724229 UNKNOWN INFUSION PUMP PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION NEU_UNKNOWN_PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 00054 YR Hospitalization| L| R