BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANTABLE INFUSION PUMP

    MDR report key: 5700798 · Received June 6, 2016

    Report

    Report Number
    3007566237-2016-02200
    Event Type
    Injury
    Date Received
    June 6, 2016
    Date of Event
    November 19, 2015
    Report Date
    June 6, 2016
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS NOT POSSIBLE TO MATCH THIS EVENT WITH ANY PREVIOUSLY REPORTED EVENT. 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.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    JAMES, L., WUNNAVA, M. UNUSUAL REIMPLANTATION OF BACLOFEN PUMP WITH COMPLICATED WEAN AND WITHDRAWAL: A CASE REPORT. REGIONAL ANESTHESIA AND PAIN MEDICINE. 2016. 41(2). ABSTRACT 798. SUMMARY/REPORTED EVENTS: A (B)(6) FEMALE WITH HISTORY OF SEVERE SYSTEMIC SPASTICITY SECONDARY TO TRAUMATIC BRAIN INJURY DUE TO MOTOR VEHICLE COLLISION AT THE AGE OF (B)(6). THE PATIENT PRESENTED TO OUTPATIENT PAIN MEDICINE CLINIC WITH PREEXISTING INTRATHECAL BACLOFEN PUMP. SHE REQUIRED ROUTINE REVISION OF THE INTRATHECAL DRUG DELIVERY SYSTEM DUE TO MANUFACTURER PROTOCOL AND WAS SET UP FOR REVISION SURGERY. THE PATIENT¿S SURGICAL COURSE WAS COMPLICATED BY POOR POST-OP WOUND HEALING AND DESPITE CONSERVATIVE MEASURES, SHE DEVELOPED POSTOPERATIVE INFECTION REQUIRING ADMISSION TO INPATIENT HOSPITAL FOR INTRAVENOUS ANTIBIOTICS. THE PATIENT UNDERWENT INTRATHECAL BACLOFEN WEAN AND SUBSEQUENT WITHDRAWAL. SHE WAS STARTED ON ORAL BACLOFEN AND DANTROLENE AND THE INTRATHECAL DRUG DELIVERY SYSTEM WAS EXPLANTED BY NEUROSURGERY, BUT SHE CONTINUED TO HAVE SEVERE FUNCTIONAL IMPAIRMENTS DUE TO UNCONTROLLED SPASTICITY. THE INTRATHECAL DRUG DELIVERY SYSTEM WAS REIMPLANTED 35 DAYS AFTER EXPLANTATION WHILE STILL ON INTRAVENOUS ANTIBIOTICS DUE TO HER POOR FUNCTIONAL PERFORMANCE, THAT WAS A BARRIER FOR SELF CARE AND SAFE DISCHARGE. FOLLOWING REIMPLANTATION, THERE WERE NO SURGICAL COMPLICATIONS UPON FOLLOW UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    355869 IMPLANTABLE INFUSION PUMP PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION NEU_UNKNOWN_PUMP UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Hospitalization| R