BEUDAMED
    FDA Adverse Event Other Summary report: N

    NONE

    MDR report key: 2020312 · Received March 11, 2011

    Report

    Report Number
    9612007-2011-00010
    Event Type
    Other
    Date Received
    March 11, 2011
    Report Date
    March 11, 2011
    Manufacturer
    INTEGRA, BIOT
    Product Code
    JXG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFO.

    Description of Event or Problem · 1

    PUBLICATION FROM CLINICAL NEUROLOGY AND NEUROSURGERY 112 (2010) 832-834 DESCRIBED A CASE REPORT ABOUT A PT DIAGNOSED WITH A PSEUDOTUMOR CEREBRI WHO UNDERWENT THE PLACEMENT OF AN LP SHUNT CONTAINING A HORIZONTAL-VERTICAL LUMBAR VALVE SYSTEM (INTEGRA). SECONDARY CHIARI MALFORMATION DEVELOPMENT AFTER LP SHUNTING FOR PSEUDOTUMOR CEREBRI IS A RECOGNIZED PHENOMENON. (B)(6) MONTHS POSTOPERATIVELY, THE PT WAS NOTED TO HAVE A SEROMA AT HER ABDOMINAL INCISION SITE. SHE UNDERWENT A REVISION OF THE ABDOMINAL-CATHETER PORTION OF THE LP SHUNT; CULTURES OBTAINED FROM THE SITE WERE NEGATIVE. HER SYMPTOMS IMPROVED; HOWEVER, FOUR MONTHS LATER ((B)(6) MONTHS FROM THE INITIAL LP SHUNT PLACEMENT), SHE WAS DIAGNOSED WITH A CHIARI MALFORMATION. THERE WAS NO ASSOCIATED SPINAL CORD SYRINX. THE PT UNDERWENT A SUBOCCIPITAL DECOMPRESSION OF THE CHIARI MALFORMATION. THERE WERE NO PERIOPERATIVE COMPLICATIONS. THE PT EXHIBITED NEUROLOGICAL SYMPTOMS AT (B)(6) MONTHS POST DECOMPRESSION AND WAS DIAGNOSED BY MRI WITH AN EXPANDED SPINAL CORD SYRINX THAT EXTENDED FROM C2 TO THE THORACIC SPINE. THE PT UNDERWENT LP SHUNT LIGATION AND VP SHUNT PLACEMENT. AT THE (B)(6) MONTH FOLLOW-UP, THE PATIENT'S SYMPTOMS HAD IMPROVED AND A CERVICAL SPINE MR IMAGING SHOWED NO EVIDENCE OF A SPINAL CORD SYRINX.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NONE JXG INTEGRA, BIOT UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Other