BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK

    MDR report key: 953592 · Received November 27, 2007

    Report

    Report Number
    1121308-2007-00015
    Event Type
    Injury
    Date Received
    November 27, 2007
    Date of Event
    January 19, 2007
    Report Date
    November 27, 2007
    Manufacturer
    INTEGRA LIFESCIENCES
    Product Code
    GXQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFO.

    Description of Event or Problem · 1

    INTEGRA LIFESCIENCES CORP ("INTEGRA") REC'D A LETTER FROM THE PT'S REP DATED 09/20/2007, ALLEGING THAT THE PT REQUIRED EMERGENCY SURGERY TO REPAIR A CRANIAL SPINAL FLUID ("CSF") LEAK. ACCORDING TO THE LETTER, THE SURGEON, WHO PERFORMED THE EMERGENCY SURGERY, NOTED THAT THE "DURAGEN PATCH" HAD "VIRTUALLY DISSOLVED." INTEGRA REQUESTED FURTHER INFO TO DETERMINE IF THIS INCIDENT HAD BEEN PREVIOUSLY REPORTED BY THE USER FACILITY. THE REQUESTED INFO WAS REC'D ON 10/23/2007. INTEGRA'S COMPLAINT DATABASE WAS SEARCHED WITH THE NEW INFO AS CRITERIA. NO RECORD WAS REC'D BY INTEGRA IN REGARDS TO THE INCIDENT FROM THE USER FACILITY. IN 2006, THE PT WAS ADMITTED FOR A SUBOCCIPITAL CRANIOTOMY AND GROSS RESECTION OF CEREBELLAR LESION. GROSS TOTAL RESECTION WAS ACHIEVED. FOLLOWING RESECTION THE CAVITY WAS LINED WITH SURGICEL AND HEMOSTASIS ACHIEVED AND CHECKED WITH VALSALVA. A SUTURABLE DURAGEN PATCH WAS THEN CUT AND SEWN IN WITH A RUNNING SUTURE. IT WAS THEN COVERED WITH DURASEAL AND VASALVA WAS USED TO CHECK FOR CSF LEAKS. THE WOUND WAS CLOSED IN LAYERS IN THE USUAL FASHION. APPROXIMATELY THREE WEEKS POST SURGERY, THE PT WAS EXPERIENCING HEADACHES THAT THE PHYSICIAN BELIEVED TO BE RELATED IN PART TO HER SINUS PROBLEMS. SHE STATED NOW SHE IS HAVING SOME HEARING CHANGES IN HER RIGHT EAR AND SHE SAID THE OTHER NIGHT WHEN SHE WENT TO LAY DOWN THAT SHE REALLY COULD FEEL HER HEART BEAT IN HER HEAD AND HER RIGHT EAR. A CT SCAN OF HER HEAD, TAKEN ON 01/08/2007, SHOWED HER VENTRICLES TO BE NORMAL. THERE WAS AN AREA OF A LITTLE PSEUDOMENINGOCELE AT THE INCISION AREA. HOWEVER, IT WAS MINOR AND OTHERWISE LOOKED TO BE WITHIN NORMAL POSTOPERATIVE CONDITIONS. IN 2007, STILL COMPLAINING OF HEADACHE, SHE WAS GIVEN MEDROL DOSE PACK FOR IMMEDIATE RELIEF OF THIS HEADACHE. SHE CALLED AGAIN ELEVEN DAYS LATER, SAYING THAT SHE HAD LEAKING FROM HER INCISION. A SECOND SURGERY WAS PERFORMED ON THE SAME DAY, TO EXPLORE THE WOUND AND CLOSE THE LEAK. THE SURGICAL FINDINGS INCLUDED A LEAKAGE OF CEREBROSPINAL FLUID. THE PHYSICIAN NOTED THAT THE "DURAGEN," WHICH HAD BEEN SUTURED, HAD VIRTUALLY DISSOLVED. THERE WAS CSF ISSUING, NOT ONLY FROM THE SUTURE LINE, BUT ALSO THROUGH THE CENTER OF THIS MATERIAL. A FOLLOW UP AS OF THE FOLLOWING MONTH, NOTED THAT THE PT STATES THAT SHE HAS DONE FAIRLY WELL SINCE HER RECENT SURGERY. SHE DENIES MUCH IN THE WAY OF HEADACHE AND NO DRAINAGE FROM THE WOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNK DURAL GRAFT GXQ INTEGRA LIFESCIENCES

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention SURGICEL| POST-OPERATIVE - ADVIL PRN| VALSALVA| DURASEAL| PRE-OPERATIVE - ADVIL PRN, DURING OPERATION| MEDROL| SUDAFED