BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED

    MDR report key: 1650652 · Received April 1, 2010

    Report

    Report Number
    3007566237-2010-02683
    Event Type
    Injury
    Date Received
    April 1, 2010
    Date of Event
    February 14, 2010
    Report Date
    March 16, 2010
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4).

    Description of Event or Problem · 1

    LITERATURE: MUNTS AG, VOORMOLEN JH, MARINUS J. DELHAAS EM, VAN HILTEN JJ. POSTDURAL PUNCTURE HEADACHE IN COMPLEX REGIONAL PAIN SYNDROME: A RETROSPECTIVE OBSERVATIONAL STUDY. PAIN MED. NOV 2009; 10(8): 1469-1475. SUMMARY: THIS ARTICLE DESCRIBES THE UNUSUAL COURSE OF POSTDURAL HEADACHE (PDPH) AFTER PUMP IMPLANTATION FOR INTRATHECAL BACLOFEN (ITB) ADMINISTRATION IN PTS WITH COMPLEX REGIONAL PAIN SYNDROME (CRPS)-RELATED DYSTONIA. THE INFO IS CASE SERIES BASED ON DATA COLLECTED FROM 1996 TO 2005 ON A TOTAL OF 54 PTS WITH CRPS-RELATED DYSTONIA WHO WERE TREATED WITH ITB. REPORTABLE EVENT: FOUR OF ELEVEN PTS WITH PDPH, WITHOUT CSF LEAK, HAD EBP WHICH WAS REPEATED TWICE WITHOUT RESULTS. IT WAS ALSO NOTED, SIX PTS WITH PDPH BUT WITHOUT CSF LEAK RECEIVED IV KETAMINE. PDPH RESOLVED IN FOUR PTS DURING 2 - 10 DAYS OF TREATMENT. IN TWO OF THESE PTS, A PRIOR EBP HAD NO EFFECT. IV KETAMINE GAVE NO IMPROVEMENT IN TWO PTS, ONE OF WHOM ALSO HAD A PRIOR EBP WITHOUT EFFECT. THESE PTS WERE NOT SPECIFIED. IT WAS FURTHER NOTED, FOURTEEN OF FIFTEEN PTS WHO EXPERIENCED EXACERBATION OF THEIR CRPS ALSO HAD PDPH WITHOUT CSF LEAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED LKK MEDTRONIC NEUROMODULATION PUMP NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention IMPLANTED:| EXPLANTED:| CATHETER: MODEL UNK, SERIAL# UNK