BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANTABLE INFUSION PUMP

    MDR report key: 5700956 · Received June 6, 2016

    Report

    Report Number
    3007566237-2016-02202
    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
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS NOT POSSIBLE TO MATCH THIS EVENT WITH ANY PREVIOUSLY REPORTED EVENT. CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: NEU_UNKNOWN_CATH, 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.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    REZVI, U., MALIK, T. INADVERTENT SUBDURAL BACLOFEN PUMP PLACEMENT FOR A REFRACTORY CASE OF MULTIPLE SCLEROSIS LEADING TO INTRATHECAL REVISION: A CALL FOR MORE RIGOROUS IMAGE GUIDED FOLLOW-UP STANDARDS FOR INTRATHECAL PUMP PLACEMENT. REGIONAL ANESTHESIA AND PAIN MEDICINE. 2016. 41(2). ABSTRACT 1159. SUMMARY/REPORTED EVENTS: THE PATIENT IS A (B)(6) FEMALE WITH AN 11 YEAR HISTORY OF RELAPSING AND REMITTING MULTIPLE SCLEROSIS WHO PRESENTED INITIALLY TO NEUROSURGERY CLINIC FOR INTRATHECAL BACLOFEN PUMP PLACEMENT. HER SYMPTOMS WERE NOT WELL CONTROLLED WITH HER CURRENT REGIMEN OF ORAL BACLOFEN, METHYLPREDNISOLONE TAPERS, TIZANIDINE, TERBUTALINE FOR URINARY URGENCY, AND TOPIRAMATE AS WELL AS BOTOX INJECTIONS FOR BLADDER SPASTICITY AND AGGRESSIVE PHYSICAL THERAPY. SHE HAD PREVIOUSLY FAILED MEDICAL MANAGEMENT WITH GLATIRAMER, 4-AMINOPYRIDINE, NATALIZUMAB, CLADIRIBINE, BETA-INTERFERON, AND FINGOLIMOD. HER DISEASE PROGRESSION WAS CONTRIBUTING TO WORSENING CLASP KNIFE SPASTICITY, GAIT IMBALANCE CONTRIBUTING TO FREQUENT FALLS, AND COGNITIVE DECLINE. INTRATHECAL PUMP PLACED BY NEUROSURGERY WITHOUT ANY NOTED COMPLICATIONS. POST-OPERATIVE COURSE COMPLICATED BY PDPH REQUIRING EPIDURAL BLOOD PATCH. AFTERWARDS, SHE WAS REQUIRING FREQUENT INCREASES IN INTRATHECAL BACLOFEN PUMP DOSAGE. INITIAL CATHETER CHECK BY ANESTHESIA PAIN CLINIC UNDER FLUOROSCOPIC GUIDANCE DEMONSTRATED QUESTIONABLE INTRATHECAL SPREAD OF DYE AND AN INABILITY TO ASPIRATE CSF WAS NOTED. PATIENT CONTINUED TO NOTE MINIMAL IMPROVEMENT IN SYMPTOMS DESPITE FREQUENT BOLUS DOSES AND INCREASED ORAL BACLOFEN DOSE. REPEAT DYE TEST WITH CT SCAN SUBSEQUENTLY SHOWED SUBDURAL PLACEMENT OF CATHETER TIP WITH POSSIBLE COMMUNICATION WITH ARACHNOID MEMBRANES CONTRIBUTING TO MILD SYMPTOMATIC IMPROVEMENTS. AFTER PUMP REVISION, INTRATHECAL PLACEMENT CONFIRMED WITH INTRA-OP OMNIPAQUE ADMINISTRATION, PATIENT NOTED TO HAVE SIGNIFICANT SYMPTOMATIC IMPROVEMENTS WITH LOWER BASAL DOSE OF INTRATHECAL BACLOFEN AND WAS ABLE TO DISCONTINUE PO BACLOFEN USAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    355644 IMPLANTABLE INFUSION PUMP PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION NEU_UNKNOWN_PUMP UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Required Intervention