BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSION PUMP

    MDR report key: 3103191 · Received May 9, 2013

    Report

    Report Number
    3007566237-2013-01573
    Event Type
    Injury
    Date Received
    May 9, 2013
    Date of Event
    December 13, 2012
    Report Date
    April 23, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID NEU_UNKNOWN_CATH, SERIAL# UNKNOWN. PRODUCT TYPE: CATHETER. THE ACTUAL EVENT DATES WERE NOT PROVIDED; THIS DATE IS BASED ON THE DATE THE ARTICLE WAS RECEIVED FOR PUBLICATION. IT WAS NOT POSSIBLE TO MATCH THESE EVENTS WITH ANY PREVIOUSLY REPORTED EVENTS. (B)(4).

    Description of Event or Problem · 1

    NEUMAN, S. A., ELDRIGE, J. S., QU, W., FREEMAN, E. D., HOELZER, B. C. POST DURAL PUNCTURE HEADACHE FOLLOWING INTRATHECAL DRUG DELIVERY SYSTEM PLACEMENT. PAIN PHYSICIAN. 2013;16(2):101-107. SUMMARY: THOUGH OTHER PAPERS EXIST THAT DESCRIBE VARIOUS TREATMENT OPTIONS FOR PDPH, WE WERE ABLE TO DESCRIBE TREATMENT OUTCOMES FOR PDPH AFTER IDSS IMPLANTATION OVER A 20 YEAR RETROSPECTIVE REVIEW AT A SINGLE ACADEMIC CENTER (16,18,19). THE PRIMARY AIM OF OUR STUDY WAS TO DETERMINE THE OVERALL INCIDENCE OF PDPH IN PATIENTS UNDERGOING PLACEMENT OF IDDSS, TO IDENTIFY ANY PREDISPOSING CHARACTERISTICS FOR DEVELOPMENT OF PDPH, AND TO REPORT ON THE SUCCESS OF THERAPEUTIC MEASURES EMPLOYED TO TREAT PDPH. REPORTED EVENTS: 15 OF THE 73 PATIENTS WHO EXPERIENCED POST DURAL HEADACHE FOLLOWING IDDS PLACEMENT REQUIRED PROCEDURAL INTERVENTION IN THE FORM OF AN EPIDURAL BLOOD PATCH OR AN EPIDURAL FIBRIN GLUE PATCH. TWO OF THE 15 PATIENTS REQUIRED A 2ND EPIDURAL PATCH PROCEDURE IN ORDER TO ACHIEVE LASTING RELIEF. ALL OF THESE PATIENTS HAD A FULL RESOLUTION OF SYMPTOMS. APPROXIMATELY 23 OF THE 285 PATIENTS REQUIRED 2-6 DURAL PUNCTURES PRIOR TO SUCCESSFUL CATHETER THREADING. ADDITIONAL INFORMATION IS BEING REQUESTED AT THIS TIME; A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203426 INFUSION PUMP PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION NEU_UNKNOWN_PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention