BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LP SHUNT

    MDR report key: 3820610 · Received May 20, 2014

    Report

    Report Number
    1226348-2014-11654
    Event Type
    Injury
    Date Received
    May 20, 2014
    Product Code
    JXG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IT HAS BEEN COMMUNICATED THAT THE DEVICE AND/OR LOT INFORMATION IS NOT AVAILABLE FOR EVALUATION. WITHOUT THE DEVICE AND/OR LOT INFORMATION IT IS NOT POSSIBLE FOR CODMAN TO CONDUCT A PROPER INVESTIGATION. IF AT SOME POINT THE DEVICE AND/OR LOT INFORMATION DOES BECOME AVAILABLE, THIS COMPLAINT WILL BE RE-OPENED, EVALUATED AND A FOLLOW UP REPORT WILL BE FILED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR COMPLAINTS. AT THE PRESENT TIME THIS COMPLAINT IS CONSIDERED CLOSED. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    THE ARTICLE REPORTED: CEREBROSPINAL FLUID (CSF) OVERDRAINAGE AFTER LUMBOPERITONEAL (LP) SHUNT PLACEMENT FOR THE PATIENTS WITH IDIOPATHIC NORMAL PRESSURE HYDROCEPHALUS (INPH) IS MAINLY CAUSED BY INSUFFICIENT MANAGEMENT OF PRESSURE SETTINGS OF THE SHUNT VALVE AND/OR SIPHON EFFECT OF SHUNT SYSTEMS INDUCED BY THE PATIENT¿S POSTURAL CHANGES. WE HERE REPORT A UNIQUE CASE OF INTRACRANIAL HYPOTENSION (IH) DUE TO CSF LEAKAGE AFTER LP SHUNT PLACEMENT IN WHICH ANOTHER MECHANISM LEADS TO THE CSF LEAKAGE. A (B)(6) MAN SUFFERED FROM PERSISTENT HEADACHE WORSENING WITH POSTURAL CHANGE 2 MONTHS AFTER LP SHUNT RECONSTRUCTION FOR INPH. BRAIN COMPUTED TOMOGRAPHY SCAN SHOWED BILATERAL CHRONIC SUBDURAL HEMATOMAS (CSDH). LUMBAR IMAGES INCLUDING SHUNTOGRAPHY AND MAGNETIC RESONANCE IMAGING SHOWED THE TIP OF THE LUMBAR CATHETER WAS SPONTANEOUSLY PULLED OUT CLOSE TO THE DURA MATER WITH EXPANSION OF THE EPIDURAL SPACE DUE TO CSF LEAKAGE FROM A SHUNT SIDE HOLE OF THE LUMBAR CATHETER TO THE EPIDURAL SPACE. SHUNT REMOVAL AND SUBSEQUENT IRRIGATION OF CSDH IMPROVED HIS HEADACHE. CSF LEAKAGE IN OUR CASE DIFFERS FROM THOSE IN PREVIOUS REPORTS, BECAUSE EARLY AND ENORMOUS CSF LEAKAGE INTO THE EPIDURAL SPACE CAN BE EXPLAINED ONLY BY A DIFFERENT MECHANISM THROUGH A SIDE HOLE JUST LOCATED IN THE EPIDURAL SPACE IN OUR CASE. WE MUST PAY ATTENTION TO THE POSSIBILITY OF THIS RARE CAUSE OF IH DUE TO CSF LEAKAGE IN PATIENTS SUFFERING FROM POSTURAL HEADACHE AFTER LP SHUNT PLACEMENT. ADDITIONAL INFORMATION FROM THE AFFILIATE STATED: THE PATIENT IS NOW DOING WELL (KPS 90%) AFTER THE LAST VP SHUNT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300050 LP SHUNT SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention