BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVUS VALVE, MEDIUM PRESSURE

    MDR report key: 8232191 · Received January 9, 2019

    Report

    Report Number
    2648988-2019-00005
    Event Type
    Injury
    Date Received
    January 9, 2019
    Report Date
    December 14, 2018
    Manufacturer
    INTEGRA NEUROSCIENCES PR
    Product Code
    JXG
    PMA / PMN Number
    K961859
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    NO COMPLAINT UNIT WILL BE RETURNED SINCE THIS COMPLAINT CORRESPONDS TO A RETROSPECTIVE REVIEW FROM MARCH 1998 AND JUNE 2007. BASED ON THE ABSENCE OF LOT AND CATALOG INFORMATION OF THE PRODUCTS USED, IT IS NOT POSSIBLE TO IDENTIFY THE MANUFACTURING TIME FRAME TO BE REVIEWED AND, THEREFORE, IT WAS NOT POSSIBLE TO PERFORM THE DHR REVIEW AND NEITHER EVENT/NC, CAPA, SCAR HISTORIES REVIEW. NO FAILURE ANALYSIS IS POSSIBLE. THE REPORTED CONDITION IS UNCONFIRMED. THE ROOT CAUSE IS UNDETERMINED.

    Description of Event or Problem · 0

    N/A.

    Additional Manufacturer Narrative · 1

    THE DEVICE IS NOT EXPECTED TO BE RETURNED TO THE MANUFACTURER FOR ANALYSIS. THE PLANT INVESTIGATION IS IN PROGRESS AND A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION. (B)(4). LINKED TO MFG REPORT NUMBERS: 2648988-2019-00004 AND 2648988-2019-00006.

    Description of Event or Problem · 1

    INTRACRANIAL PRESSURE AND BRAIN MONITORING XIV PUBLISHED (2012) "IDIOPAHIC NORMAL PRESSURE HYRDOCEPHALUS : RESULTS OF PROSPECTIVE COHORT OF 236 SHUNTED PATIENTS." AIM : TO DESCRIBE THE OUTCOMES AND COMPLICATION RATES IN 236 PATIENTS WITH IDIOPATHIC NORMAL PRESSURE HYDROCEPHALUS(INPH) AFTER TREATMENT. PATIENTS AND METHODS: BETWEEN MARCH 1998 AND JUNE 2007, 257 CONSECUTIVE PATIENTS WITH SUSPECTED INPH SYNDROME WERE EVALUATED IN THE DEPARTMENT OF NEUROSURGERY AT A UNIVERSITY HOSPITAL. AMONG A COHORT OF 257 PATIENTS WITH SUSPECTED INPH, 244 WERE SHUNTED AND 236 WERE FOLLOWED UP AT 6 MONTHS AFTER SHUNTING (145 MEN [61.4%] AND 91 WOMEN [38.6%] WITH A MEDIAN AGE OF 75 YEARS). THE STUDY PROTOCOL OF THESE PATIENTS INCLUDED CLINICAL, RADIOLOGICAL, NEUROPSYCHOLOGICAL AND FUNCTIONAL ASSESSMENT. THE DECISION TO SHUNT PATIENTS WAS BASED ON CONTINUOUS INTRACRANIAL PRESSURE MONITORING AND CSF DYNAMICS STUDIES. A DIFFERENTIAL LOW-PRESSURE VALVE SYSTEM, ALWAYS COMBINED WITH A GRAVITY COMPENSATING DEVICE, WAS IMPLANTED IN 99% OF THE PATIENTS. DIFFERENTIAL LOW-PRESSURE VALVE SYSTEM WAS IMPLANTED AND COMBINED WITH A GRAVITY COMPENSATING DEVICE IN 233 OF THE 236 PATIENTS. IN THE REMAINING THREE PATIENTS, A MEDIUM PRESSURE VALVE WITH AN ANTISIPHON DEVICE WAS IMPLANTED. THE TYPES OF VALVE USED IN THE PRESENT SERIES WERE PROGRAMMABLE HAKIM MEDOS VALVE (MEDOS S.A.) + LOW-PRESSURE GRAVITY COMPENSATING ACCESSORY (GCA) (NMT NEUROSCIENCES IMPLANTS), DELTA VALVE (PERFORMANCE LEVEL OF 0.5) WITH ANTISIPHON DEVICE (MEDTRONIC PS MEDICAL), VENTRICULO-PERITONEAL CATHETER WITH A LOW-PRESSURE GCA (NMT NEUROSCIENCES IMPLANTS), DUAL SWITH MIETKE (BRAUN-AESCULAP), HAKIM MEDOS VALVES (NMT NEUROSCIENCES IMPLANTS), LOW-PRESSURE NOVUS VALVE WITH AN ANTISIPHON (INTEGRA), AND MEDIUM-PRESSURE NOVUS VALVE WITH AN ANTISIPHON (INTEGRA). RESULTS: EARLY POSTSURGICAL COMPLICATIONS WERE FOUND IN 13 OF THE 243 SHUNTED PATIENTS (FOUR (4) SUBDURAL HEMATOMA, TWO (2) SHUNT MALFUNCTIONS, FOUR (4) SYSTEMIC COMPLICATIONS, ONE (1) POSTURAL HYPOACUSIA, ONE (1) PARENCHYMAL HEMATOMA, ONE (1) HEMORRHAGIC COMPLICATION WHEN THE BURR HOLE WAS PERFORMED). SIX MONTHS AFTER SHUNTING, THE FOLLOW- UP CT SHOWED ASYMPTOMATIC SUBDURAL COLLECTIONS (HYGROMAS) IN 8 OF THE 236 PATIENTS WHO REMAINED UNDER FOLLOW-UP. NONE OF THESE PATIENTS REQUIRED TREATMENT. OF THE 236 PATIENTS, POST-SURGICAL COMPLICATIONS WERE FOUND IN 7, CONSISTING OF 6 SUBDURAL HEMATOMAS (3 ACUTE AND 3 CHRONIC) AND A DISTAL CATHETER INFECTION. NO SHUNT MALFUNCTIONS WERE OBSERVED IN THIS PERIOD. CONCLUSION: A HIGH PERCENTAGE OF PATIENTS WITH INPH CAN IMPROVE AFTER SHUNTING, WITH EARLY AND LATE COMPLICATION RATES OF LESS THAN 12%.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    24997 NOVUS VALVE, MEDIUM PRESSURE SHUNTS JXG INTEGRA NEUROSCIENCES PR

    Patients

    Seq Age Sex Outcome Treatment
    1