BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANTABLE INFUSION PUMP

    MDR report key: 6077147 · Received November 3, 2016

    Report

    Report Number
    3007566237-2016-03894
    Event Type
    Injury
    Date Received
    November 3, 2016
    Date of Event
    July 4, 2016
    Report Date
    November 3, 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 MEDICAL PRODUCTS: PRODUCT ID NEU_UNKNOWN_CATH, PRODUCT TYPE: CATHETER. 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.

    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: MASTER: A CHART REVIEW UNCOVERED POST-DURAL PUNCTURE HEADACHE (PDPH) SYMPTOMS IN 73 PATIENTS. OF THE PATIENTS WITH PDPH, 15 PATIENTS HAD SYMPTOMS REFRACTORY TO CONSERVATIVE TREATMENT AND REQUIRED 17 EPIDURAL BLOOD PATCH PROCEDURES. ALL PATIENTS REVIEWED ACHIEVED RELIEF OF THE PDPH SYMPTOMS; TWO PATIENTS WERE FOUND TO HAVE PERSISTENT CERBROSPINAL FLUID LEAK THAT REQUIRED REOPERATION WITH PURSE-STRING SUTURE PLACEMENT AND/OR SURGICAL FIBRIN GLUE PLACEMENT AT THE INTRATHECAL DRUG DELIVERY SYSTEM (IDDS) CATHETER ENTRANCE SITE. ALL PATIENTS REVIEWED ACHIEVED RELIEF OF THE PDPH SYMPTOMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    726258 IMPLANTABLE INFUSION PUMP PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION NEU_UNKNOWN_PUMP UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention