BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANTABLE INFUSION PUMP

    MDR report key: 6800448 · Received August 17, 2017

    Report

    Report Number
    3007566237-2017-03333
    Event Type
    Injury
    Date Received
    August 17, 2017
    Date of Event
    September 10, 2003
    Report Date
    August 17, 2017
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS NOT POSSIBLE TO MATCH THIS EVENT WITH ANY PREVIOUSLY REPORTED EVENT. INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM AND OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: NEU_UNKNOWN_CATH, LOT# SERIAL# UNKNOWN, PRODUCT TYPE: CATHETER. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    STAAL, C., ARENDS, A., HO, S. A SELF-REPORT OF QUALITY OF LIFE OF PATIENTS RECEIVING INTRATHECAL BACLOFEN THERAPY. REHABILITATION NURSING. 2003. 28(5):159-63. DOI: 10.1002/J.2048-7940.2003.TB02050. SUMMARY: THE PURPOSE OF THIS STUDY WAS TO EXPLORE THROUGH A DEPARTMENT QUALITY IMPROVEMENT TOOL A POSSIBLE RELATION BETWEEN QUALITY OF LIFE (QOL), COMPLICATION RATES, AND LENGTH OF INTRATHECAL BACLOFEN (IB) TREATMENT AS REPORTED BY PATIENTS RECEIVING IB THERAPY IN A COMMUNITY BASED REHABILITATION CENTER OUTPATIENT CLINIC. REPORTED EVENTS: THE MOST COMMON COMPLICATIONS CITED WERE INFECTION AND CATHETER BREAKAGE OR DISCONNECT. THE OVERALL INFECTION RATE FOR RESPONDENTS WAS 10% (5 PATIENTS OF THE 49 SURVEYED REPORTED INFECTION). THE MOST COMMON COMPLICATIONS CITED WERE INFECTION AND CATHETER BREAKAGE OR DISCONNECT. THE RATE OF CATHETER BREAKAGE OR DISCONNECT WAS 10%.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    582053 IMPLANTABLE INFUSION PUMP PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION NEU_UNKNOWN_PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 Other