BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANTABLE INFUSION PUMP

    MDR report key: 6079412 · Received November 4, 2016

    Report

    Report Number
    3007566237-2016-03913
    Event Type
    Injury
    Date Received
    November 4, 2016
    Date of Event
    July 4, 2016
    Report Date
    November 4, 2016
    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. CONCOMITANT PRODUCTS: PRODUCT ID: NEU_UNKNOWN_CATH, 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

    BENDEL, M.A., MOESCHLER, S.M., QU, W., HANLEY, E., NEUMAN, S.A., ELDRIGE, J.S., HOELZER, B.C. TREATMENT OF REFRACTORY POSTDURAL PUNCTURE HEADACHE AFTER INTRATHECAL DRUG DELIVERY SYSTEM IMPLANTATION WITH EPIDURAL BLOOD PATCH PROCEDURES: A 20-YEAR EXPERIENCE. PAIN RESEARCH AND TREATMENT. 2016. 2134959. (1-5). DOI: 10.1155/2016/2134959. SUMMARY: THIS STUDY AIMS TO PROVIDE A RETROSPECTIVE REPORT OF EPIDURAL BLOOD PATCH (EBP) FOR PATIENTS SUFFERING FROM POSTDURAL PUNCTURE HEADACHE (PDPH) RELATED TO INTRATHECAL DRUG DELIVERY SYSTEM (IDDS) IMPLANTATION. REPORTED EVENTS: A (B)(6) MALE WITH AN INDICATION OF PROSTATE CANCER HAD THEIR CATHETER LEVEL AT T10-11. THE PATIENT HAD A POST-DURAL PUNCTURE HEADACHE (PDPH). THE PATIENT HAD SYMPTOMS REFRACTORY TO CONSERVATIVE TREATMENT THAT INCLUDED BEDREST, INTRAVENOUS (IV) FLUIDS, AND CAFFEINE. THE EVENT REQUIRED AN EPIDURAL BLOOD PATCH AT T10-11. THE PATIENT WAS FOUND TO HAVE PERSISTENT CEREBROSPINAL FLUID (CSF) LEAK DESPITE INITIAL BLOOD PATCHING. ULTIMATELY IT REQUIRED REOPENING OF THE INCISION AND PLACEMENT OF A PURSE-STRING STITCH AND/OR FIBRIN GLUE ALONG THE CATHETER INSERTION SITE. ALL PATIENTS REVIEWED ACHIEVED RELIEF OF THE PDPH SYMPTOMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    730383 IMPLANTABLE INFUSION PUMP PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION NEU_UNKNOWN_PUMP UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention