BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICRO CHPV W RICKHAM UNITIZED

    MDR report key: 18302511 · Received December 11, 2023

    Report

    Report Number
    3013886523-2023-00441
    Event Type
    Injury
    Date Received
    December 11, 2023
    Date of Event
    December 1, 2023
    Report Date
    April 5, 2024
    Manufacturer
    INTEGRA LIFESCIENCES MANSFIELD
    Product Code
    JXG
    UDI-DI
    10381780519164
    PMA / PMN Number
    K053107
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE HAKIM VALVE (ID 823113) WAS NOT RETURNED FOR EVALUATION AND LOT NUMBER INFORMATION HAS NOT BEEN PROVIDED; THEREFORE, AN EVALUATION OF THE DEVICE COULD NOT BE PERFORMED, AND DEVICE HISTORY RECORD (DHR) COULD NOT BE REVIEWED. THE ROOT CAUSE(S) OF THE REPORTED ISSUE COULD NOT BE DETERMINED. HOWEVER, A PROBABLE ROOT CAUSE FOR THE REPORTED COMPLAINT IS DUE TO BIOLOGICAL DEBRIS AND PROTEIN BUILD UP INTERFERING WITH THE DEVICE. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE IN THE FUTURE, THIS COMPLAINT WILL BE REOPENED, AND THE RESPECTIVE EVALUATION PERFORMED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR ISSUES. AT PRESENT, WE CONSIDER THIS COMPLAINT TO BE CLOSED.

    Additional Manufacturer Narrative · 0

    LINKED TO MFG REPORT NUMBER: 3013886523-2021-00259. ADDITIONAL INFORMATION RECEIVED PROVIDED BY PATIENT: CONFIRM THE SPECIFIC FAILURE OF THE HAKIM VALVE: "VALVE WAS SURGICALLY PLACED ON (B)(6) 2018. FIRST BLEED STARTED ABOUT THREE WEEKS LATER." "DUE TO THESE SURGERY I AM CONSIDERED DISABLED DUE TO TRAUMATIC BRAIN INJURY DUE TO THE INPUT OF THIS FAULTY DEVICE. I HAVE BEEN ON FMLA SINCE 2018 YEARLY DUE TO HEAD PAIN THAT RARELY GOES AWAY. I HAD TO HAVE 2 YEARS OF COUNSELING AND I AM ON ANXIETY MEDICINE FOREVER. NO SHORT TERM MEMORY SO I WILL NEVER BE PROMOTED BECAUSE I CAN¿T HOLD ON TO ANY NEW INFORMATION. I CAN NO LONGER DRIVE AT NIGHT DUE TO THE GLARE CAUSING COMPLETE BLINDNESS. I CAN¿T SEE ANYTHING BESIDE ME DUE TO NO PERIPHERAL VISION. THE MUSCLES IN MY JAW WERE CUT DURING THE LAST SURGERY SO JAW PAIN IS REGULAR. I NO LONGER SMILE BECAUSE I CAN¿T TELL WHEN I AM SMILING BECAUSE IT IS NUMB MOST DAYS. I HAVE NOTHING TO SMILE ABOUT ANYWAY. I CAN¿T WALK BUT A FEW FEET WITHOUT FALLING DUE TO MY GAIT." "INSTEAD OF CONTACTING YOUR COMPANY THEY HAVE SPENT THE MAJORITY OF THE TIME COVERING THIS PROBLEM UP. COVID HELP THEM OUT BECAUSE THEY COULDN¿T MEET WITH ME. I WENT TO MY DAUGHTER¿S WEDDING IN MARCH 2023 IN MIAMI FLORIDA. DURING MY VISIT I FELL WHILE STEPPING OFF A CURB, WHEN I RETURNED HOME MY NEUROLOGIST ORDERED A CT SCAN. THEY DISCOVERED THE SHUNT WAS STILL IN MY HEAD! (SEE CT SCAN PDF) THIS IS PROBABLY WHY I HAVE BURNING SENSATIONS ALL THE TIME AND PAIN EVERY TIME THE WEATHER CHANGES. THOSE THINGS DID NOT HAPPEN PRIOR TO THE IMPLANT OF THE DEVICE." CT IMPRESSION: 1. UNCHANGED SUBDURAL HEMATOMA OVER THE RIGHT CEREBRAL CONVEXITY. INTERVAL REMOVAL OF THE RIGHT SUBDURAL DRAINAGE TUBE. 2. UNCHANGED RIGHT TO LEFT MIDLINE SHIFT. IMPLANTED AREA: VENTRICLE LATERALITY: RIGHT IMPLANTED ON: (B)(6) 2018 NUMBER IMPLANTED: 1. STATUS: IMPLANTED MANUFACTURER: J&J CODMAN INSTRUMENT DIV MODEL#: 823113 LOT NUMBER: 171548. IMPRESSION: 1. INTERVAL DEVELOPMENT OF AN ACUTE CHRONIC SUBDURAL HEMORRHAGE WITH MAXIMUM THICKNESS OVERLAYING THE RIGHT FRONTAL LOBE MEASURING UP TO 1.4CM. THERE IS RESULTING LOCAL MASS EFFECT UPON THE RIGHT CEREBRAL HEMISPHERE AS WELL AS APPROXIMATELY MIDLINE SHIFT. 2. STABLE APPEARANCE OF THE FRONTAL APPROACH VENTRICULOSTOMY DRAINAGE CATHETER WITHOUT EVIDENCE OF HYDROCEPHALUS. 3. ADDITIONAL FINDINGS AS DETAILS ABOVE COMPARISON: (B)(6) 2018 TECHNIQUE: MULTIPLE AXIAL CT IMAGES OBTAINED FROM THE SKULL BASE TO VERTEX WITHOUT IV CONTRAST. FINDINGS: MINIMAL RIGHT SUBDURAL HEMATOMA. WHITE MATTER IS GROSSLY INTACT. NO INTERCRANIAL MASS, MASS EFFECT, OR MIDLINE SHIFT. VENTRICLES: SLITLIKE VENTRICLES. VISUALIZED PARANASAL SINUSES: CLEAR. VISUALIZED MASTOID AIR CELLS: CLEAR CALVARIUM: INTACT IMPRESSION: RIGHT SUBDURAL HEMATOMA AND POST CRANIOTOMY CHANGES. SHORT AXIS OF THE SUBDURAL COLLECTION IS LESS THAN A CENTIMETER. SLITLIKE VENTRICLES IN THE SETTING OF A SHUNT TUBE. IMPRESSION: 1. NO ACUTE INTRACRANIAL HEMORRHAGE. INTACT CALVARIUM 2. UNCHANGED RIGHT FRONTAL APPROACH VP SHUNT CATHETER AS DETAILED ABOVE. NO ACUTE HYDROCEPHALUS. ADDITIONAL INFORMATION RECEIVED FROM THE PATIENT: TECHNIQUE: MULTIPLE AXIAL CT IMAGES OBTAINED FROM THE SKULL BASE TO VERTEX WITHOUT IV CONTRAST. FINDINGS: INTRACRANIAL HEMORRHAGE: NO INTRACRANIAL HEMORRHAGE. VENTRICLES: UNCHANGED RIGHT FRONTAL APPROACH VP SHUNT CATHETER ENDS IN FRONTAL HORN OF LEFT LATERAL VENTRICLE. NO HYDROCEPHALUS. MIDLINE SHIFT: NONE. CALVARIUM: UNCHANGED PRIOR RIGHT CRANIOTOMY. NO ACUTE SKULL FRACTURES. BRAIN MASS: NO INTRACRANIAL MASS OR MASS EFFECT. WHITE MATTER: WHITE MATTER IS GROSSLY INTACT. VISUALIZED PARANASAL SINUSES: CLEAR. VISUALIZED MASTOID AIR CELLS: CLEAR TECHNIQUE: MULTIPLE AXIAL IMAGES OBTAINED FROM THE SKULL BASE TO THE VERTEX WITHOUT IV CONTRAST WERE OBTAINED ON 7/30/2018 8:01 AM FINDINGS: INTERVAL REMOVAL OF THE RIGHT SUBDURAL DRAINAGE TUBE. A RIGHT FRONTAL APPROACH SHUNT CATHETER REMAINS IN PLACE, TIP CROSSING THE MIDLINE ABUTTING THE LEFT BASAL GANLIA. UNCHANGED SUBDURAL HEMATOMA OVER THE RIGHT CEREBRAL CONVEXITY MEASURING UP TO 10MM IN THICKNESS OVER THE RIGHT FRONTAL LOBE. UNCHANGED RIGHT TO LEFT MIDLINES SHIFT OF APPROXIMATELY 5 TO 6 MM. NO EVIDENCE OF HYDROCEPHALUS. PARTIALLY EMPTY SELLA. NO EVIDENCE OF ACUTE LARGE TERRITORY INFARCT BY CT CRITERIA. NO DEFINITE NEW AREAS OF HEMORRHAGE. PARANASAL SINUSES: VISUALIZED PARANASAL SINUSES ARE CLEAR. MASTOID AIR CELLS: CLEAR CALVARIUM: INTACT.

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    N/A

    Description of Event or Problem · 0

    NA.

    Description of Event or Problem · 0

    IT WAS REPORTED: "ITEM MALFUNCTIONED AND HAD A BRAIN BLEEDING TWICE THAT CAUSED HER 2 EMERGENCY SURGERIES. DUE TO THIS PROBLEM SHE HAS LOSS HER VISION HAD A BLUR VISION AND HAS A SHORT TERM MEMORY. SHE IS CONSIDERED A HANDICAPPED AND DISABLED BECAUSE OF HER TRAUMATIC INJURY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1941086 MICRO CHPV W RICKHAM UNITIZED CHPV JXG INTEGRA LIFESCIENCES MANSFIELD 10381780519164

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Female