BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANTABLE INFUSION PUMP

    MDR report key: 6050604 · Received October 24, 2016

    Report

    Report Number
    3007566237-2016-03686
    Event Type
    Injury
    Date Received
    October 24, 2016
    Date of Event
    July 1, 2016
    Report Date
    October 24, 2016
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS NOT POSSIBLE TO MATCH THIS EVENT WITH ANY PREVIOUSLY REPORTED EVENT. THE MAIN COMPONENT OF THE SYSTEM AND OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: NEU_UNKNOWN_CATH, LOT# UNKNOWN, PRODUCT TYPE: CATHETER.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    FRANKLIN, A.D., MENSER, C.C., NAFTEL, R.P. FLUOROSCOPICALLY GUIDED EPIDURAL BLOOD PATCH EFFECTIVE FOR TREATMENT OF A POSTSURGICAL P SEUDOMENINGOCELE IN A PEDIATRIC PATIENT. REGIONAL ANESTHESIA AND PAIN MEDICINE. 2016. 41(4):542-543. SUMMARY/ REPORTED EVENTS: WE PRESENT THE CASE OF AN ADOLESCENT WHO, AFTER PLACEMENT OF AN INTRATHECAL BACLOFEN PUMP, DEVELOPED A POSTSURGICAL PSEUDOMENINGOCELE, WHICH RESOLVED AFTER A SINGLE FLUOROSCOPICALLY GUIDED EPIDURAL BLOOD PATCH (EBP). THE USE OF THIS TREATMENT MODALITY IN THE PEDIATRIC POPULATION HAS NOT BEEN DESCRIBED PREVIOUSLY. THE PATIENT'S LEGAL GUARDIAN HAS GIVEN PERMISSION TO PUBLISH THIS REPORT. A (B)(6) GIRL WITH CEREBRAL PALSY UNDERWENT UNEVENTFUL INTRATHECAL BACLOFEN PUMP IMPLANTATION FOR TREATMENT OF SPASTIC QUADRIPARESIS. ONE MONTH AFTER THE PROCEDURE, THE CHILD DEVELOPED PROGRESSIVELY INCREASING SUBCUTANEOUS, NONDRAINING, FLUID COLLECTIONS ADJACENT TO BOTH LUMBAR AND ABDOMINAL INCISIONS CONSISTENT WITH A POSTSURGICAL PSEUDOMENINGOCELE (FIG. 1). UNDERLYING HYDROCEPHALUS AS A CAUSATIVE FACTOR WAS RULED OUT. ATTEMPTS TO REDUCE THE PSEUDOMENINGOCELE WITH AN ABDOMINAL BINDER WERE UNSUCCESSFUL, AND THE PEDIATRIC PAIN SERVICE WAS CONSULTED FOR CONSIDERATION OF AN EBP. AFTER OBTAINING INFORMED CONSENT AND INDUCTION OF GENERAL ANESTHESIA, FLUOROSCOPY WAS USED TO LOCALIZE THE IMPLANTED INTRATHECAL PUMP AND CATHETER, WHICH ENTERED THE INTRATHECAL SPACE AT L4. THE MOST CEPHALAD PORTION OF THE PSEUDOMENINGOCELE CORRESPONDED TO THE L3/L4 INTERSPACE AS NOTED ON FLUOROSCOPY, AND SO AN L2/L3 EBP WAS PLANNED TO NOT DISRUPT THE CEREBROSPINAL FLUID FLLED PSEUDOMENINGOCELE. DYNAMIC FLUOROSCOPIC IMAGING WAS USED TO GUIDE THE TUOHY NEEDLE TO THE EPIDURAL SPACE, TAKING CARE TO AVOID LOOPS OF THE INDWELLING INTRATHECAL CATHETER TUBING. AFTER APPROPRIATE LOSS OF RESISTANCE TO SALINE AND CONFIRMATORY CONTRAST EPIDUROGRAPHY, THE PATIENT'S LEFT RADIAL ARTERY WAS CANNULATED USING DYNAMIC ULTRASOUND GUIDANCE, AS PERIPHERAL INTRAVENOUS ACCESS WAS PREVIOUSLY KNOWN TO BE DIFFICULT. STERILE BLOOD WAS DRAWN AND SLOWLY INJECTED DURING THE COURSE OF 5 MINUTES THROUGH THE EPIDURAL TUOHY NEEDLE. A TOTAL VOLUME OF 14 ML (0.5 ML/KG) WAS INJECTED BEFORE BACKPRESSURE WAS NOTED. THE TUOHY NEEDLE WAS FLUSHED WITH SALINE AND REMOVED. THE ABDOMINAL BINDER WAS REPLACED, THE PATIENT WAS TAKEN TO THE RECOVERY ROOM, AND SHE WAS KEPT IN THE SUPINE POSITION FOR 2 HOURS BEFORE DISCHARGE HOME. THE PATIENT WAS ASKED TO REMAIN IN THE ABDOMINAL BINDER FOR 3 DAYS. COMPLETE RESOLUTION WAS NOTED, AND THERE WAS NO RECURRENCE OF THE PSEUDOMENINGOCELE AT 1- AND 3-MONTH CLINIC VISITS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    702269 IMPLANTABLE INFUSION PUMP PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION NEU_UNKNOWN_PUMP UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Required Intervention