BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSION PUMP

    MDR report key: 4052024 · Received September 2, 2014

    Report

    Report Number
    3007566237-2014-02448
    Event Type
    Injury
    Date Received
    September 2, 2014
    Report Date
    August 15, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS NOT POSSIBLE TO MATCH THIS EVENT WITH ANY PREVIOUSLY REPORTED EVENT. (B)(4).

    Description of Event or Problem · 1

    FREEMAN, E.D., HOELZER, B.C., ELDRIGE, J.S., MOESCHLER, S.M. FIBRIN GLUE TO TREAT SPINAL FLUID LEAKS ASSOCIATED WITH INTRATHECAL DRUG SYSTEMS. PAIN PRACTICE. 2014; 14(6): 570-576. DOI: 10.1111/PAPR.12151 SUMMARY: INTRATHECAL DRUG DELIVERY SYSTEMS (IDDSS) ARE USED TO TREAT RESISTANT PAIN STATES AS WELL AS INTRACTABLE SPASTICITY VIA MEDICATION DELIVERY INTO THE SPINAL FLUID. RISKS ASSOCIATED WITH IMPLANTATION OF THESE DEVICES INCLUDE INFECTION, BLEEDING, INTRATHECAL GRANULOMA FORMATION, AND NEUROLOGIC SEQUELAE SIMILAR TO OTHER NEURAXIAL PROCEDURES. INTRATHECAL CATHETER PLACEMENT CREATES THE ADDITIONAL RISK OF PERSISTENT SPINAL FLUID LEAK, WHICH CAN LEAD TO POSTDURAL PUNCTURE HEADACHES AS WELL AS SEROMA FORMATION AND MAY REQUIRE SUBSEQUENT SURGICAL EXPLORATION OR EXPLANTATION. THIS RETROSPECTIVE CASE SERIES EXAMINES 3 PATIENTS AT A SINGLE INSTITUTION WITH PERSISTENT SPINAL FLUID LEAK AFTER IDDS PLACEMENT (AND EXPLANTATION IN ONE CASE) RESULTING IN HEADACHE AND/OR SEROMA FORMATION THAT WERE TREATED WITH EPIDURAL FIBRIN GLUE. THREE PATIENTSUNDERWENT IDDS IMPLANTATION WITH BACLOFEN FOR SPASTICITY. IN 1 PATIENT, A CEREBRAL SPINAL FLUID LEAK DEVELOPED AT 1-WEEK POSTOPERATIVELY. AFTER SEVERAL UNSUCCESSFUL EPIDURAL BLOOD PATCHES AND SURGICAL EXPLORATION WITH A CATHETER REVISION, SHE WAS ULTIMATELY TREATED SUCCESSFULLY WITH A FIBRIN GLUE PATCH. THE SECOND PATIENT RECEIVED AN IDDS AND DID WELL UNTIL A SEROMA DEVELOPED 1 YEAR LATER. HE WAS LIKEWISE TREATED WITH AN EPIDURAL FIBRIN GLUE PATCH AFTER 2 FAILED BLOOD PATCHES. IN A THIRD PATIENT, A SPINAL FLUID LEAK DEVELOPED AFTER EXPLANTATION OF AN IDDS AND WAS TREATED WITH AN EPIDURAL FIBRIN GLUE PATCH AS INITIAL THERAPY. REPORTED EVENTS: A (B)(6) WOMAN WITH SPASTIC ATAXIC SYNDROME WAS REFERRED FOR PLACEMENT OF AN IDDS. THREE MONTHS AFTER IDDS IMPLANTATION, THE PATIENT REPORTED INCREASED SPASTICITY UNRESPONSIVE TO ESCALATING INTRATHECAL DOSES OF BACLOFEN. AFTER VERIFYING APPROPRIATE IDDS DRUG DELIVERY TO THE CSF, BACLOFEN WAS SLOWLY WEANED AND THE IDDS WAS UNEVENTFULLY EXPLANTED. ON POSTOPERATIVE DAY ONE, THE PATIENT BEGAN COMPLAINING OF A SEVERE AND POSITIONAL HEADACHE. SHE WAS TREATED CONSERVATIVELY AS PREVIOUSLY DESCRIBED WITHOUT IMPROVEMENT IN THE HEADACHE. ON POSTOPERATIVE DAY 3, A FIBRIN GLUE PATCH WAS PLACED UNDER FLUOROSCOPIC GUIDANCE. A TOTAL OF 7 ML OF FIBRIN GLUE WAS INJECTED INTO THE EPIDURAL SPACE AT THE L1-2 LEVEL, AT WHICH POINT THE PATIENT REPORTED PRESSURE PARESTHESIA INTO THE BACK AND LEGS. THE PATIENT REPORTED NOTICEABLE RELIEF OF HER HEADACHE SYMPTOMS WITHIN 15 MINUTES, WHICH CONTINUED TO IMPROVE THROUGHOUT THE DAY. SHE HAS CONTINUED TO BE HEADACHE FREE 12 MONTH FOLLOW-UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    533694 INFUSION PUMP PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION

    Patients

    Seq Age Sex Outcome Treatment
    1 00038 YR Required Intervention