BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DUREPAIR®

    MDR report key: 17484107 · Received August 8, 2023

    Report

    Report Number
    2021898-2023-00054
    Event Type
    Injury
    Date Received
    August 8, 2023
    Date of Event
    January 31, 2023
    Report Date
    August 8, 2023
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    GXQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3) NO PARTS HAVE BEEN RETURNED FOR ANALYSIS. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    DE MARCO, R., PIATELLI, G., PORTONERO, I., FIASCHI, P., SECCI, F., PACETTI, M. PAVANELLO, M. TRANSIENT MENINGISM IN CHILDREN AFTER NON-AUTOLOGOUS DURAPLASTY FOR CHIARI MALFORMATION SURGERY: A CASE SERIES. NEUROCHIRURGIE 69 (2023) 101423 HTTPS://DOI.ORG/10.1016/ J.NEUCHI.2023.101423 BACKGROUND. INCREASING THE POSTERIOR FOSSA VOLUME IS THE MAINSTAY OF TREATMENT FOR CHIARI TYPE 1 MAL­FORMATION (CTM) AND TYPE 1.5 (CL.SM). DIFFERENT OPTIONS TO RESTORE CSF FLOW HAVE BEEN DESCRIBED BUT NO CONSENSUS HAS BEEN REACHED YET. BONY DECOMPRESSION OF POSTERIOR CRANIAL FOSSA WITH DURAL OPENING PROVIDES GOOD RESULTS BUT AT THE PRICE OF COMPLICATIONS SUCH AS PSEUDOMENINGOCELE AND ASEPTIC MENINGI­TIS. A SINGLE CENTER RETROSPECTIVE ANALYSIS WAS CONDUCTED TO FIND ANY RELATIONSHIPS BETWEEN OUTCOME AND PERIOPERATIVE FACTORS. AS A SECOND GOAL A SPECIFIC ANALYSIS WAS CONDUCTED ON THE COMPLICATIONS AND THEIR HYPOTHETICAL CAUSES. METHODS. ALL THE PEDIATRIC PATIENTS WHO UNDERWENT TO POSTERIOR FOSSA BONY DECOMPRESSION AND DURAL OPENING FOR CLM OR CL.SM IN THE PERIOD 2008-2020 WERE INCLUDED IN THE STUDY. A MINIMUM PERIOD OF THREE-MONTHS FOLLOW-UP WAS CONSIDERED AMONG THE INCLUSION CRITERIA. RESULTS. A POPULATION OF FIFTY-THREE CONSECUTIVE PATIENTS WAS COLLECTED. PSEUDOMENINGOCELE AND A MILD MENINGEAL IRRITATION RESULTED THE MOST FREQUENT COMPLICATIONS. CONSIDERING PREOPERATIVE AND INTRAOPERATIVE FACTORS, THE TYPE OF DURAL GRAFT SHOWED A RELATIVELY STRONG CORRELATION (P<.01) WITH PSEU­DOMENINGOCELE APPEARANCE AND THE DEVELOPMENT OF MENINGISM. IN THE LATTER CASE, A SHORT COURSE OF STEROIDS WAS THE ONLY TREATMENT REQUIRED TO CONTROL SYMPTOMS. CONCLUSIONS. DIFFERENT FACTORS COULD INFLUENCE THE OUTCOME IN CHIARI MALFORMATION SURGERY AND EVENTUALLY THE DEVELOPMENT OF COMPLICATIONS. AN ADEQUATE DURAL GRAFT SELECTION IS OF PARAMOUNT IMPORTANCE WHEN A DURAL OPENING FOR POSTERIOR FOSSA AUGMENTATION IS PLANNED. IN CASE OF MILD MENINGEAL IRRITATION, A TRIAL WITH SHORT COURSE STEROIDS COULD AVOID REVISION SURGERY. REPORTED EVENTS: 13 PATIENTS DEVELOPED PSEUDOMENINGOCELE ONLY TWO CASES REQUIRED LUMBAR PUNCTURES BECAUSE OF THE FAILURE OF THE FIRST ONE. ONE CASE OF HYDROCEPHALUS WITH INTRACRANIAL HYPERTENSION SIX PATIENTS COMPLAINED SYMPTOMS OF MENINGISM TWO MONTHS AFTER SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1457274 DUREPAIR® DURA SUBSTITUTE GXQ MEDTRONIC NEUROSURGERY UNKNOWN-D

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR Male Required Intervention