BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VENT RES TR SAL-RIC ST BA

    MDR report key: 18346057 · Received December 18, 2023

    Report

    Report Number
    3013886523-2023-00442
    Event Type
    Injury
    Date Received
    December 18, 2023
    Date of Event
    May 11, 2022
    Report Date
    February 16, 2024
    Manufacturer
    INTEGRA LIFESCIENCES MANSFIELD
    Product Code
    JXG
    PMA / PMN Number
    K102961
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: D4, D9, G3, G6, H2, H3, H4, H6, H10. RCKHAM RESERVOIR WAS NOT RETURNED FOR EVALUATION; THEREFORE, AN EVALUATION OF THE DEVICE COULD NOT BE PERFORMED. LOT NUMBER INFORMATION HAS BEEN PROVIDED; THEREFORE, DEVICE HISTORY RECORD (DHR) WAS REVIEWED, AND NO ANOMALIES WERE FOUND. THE ROOT CAUSE(S) OF THE REPORTED ISSUE COULD NOT BE DETERMINED. HOWEVER, A POSSIBLE ROOT CAUSE FOR THE ¿DEVICE LEAKAGE¿ ISSUE REPORTED BY THE CUSTOMER, COULD NOT BE CLEARLY DETERMINED BUT COULD BE LINKED TO A SHARP OR POINTED OBJECT COMING INTO CONTACT WITH THE DEVICE, AS NOTED IN THE IFU SILICONE HAS A LOW CUT/TEAR RESISTANCE. 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

    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

    MEDWATCH: (B)(4). STUDY: THIS CASE IS A REPORT REFERRING TO A 7 YEARS-OLD FEMALE PATIENT. AN INVESTIGATOR REPORTED THIS CASE FROM THE BIOMARIN SPONSORED STUDY (CERLIPONASE ALFA OBSERVATIONAL STUDY). "THE SUBJECT'S PAST MEDICAL HISTORY INCLUDED: GASTROSTOMY, BRONCHOSPASM, PNEUMONIA ASPIRATION, RESPIRATORY DISTRESS, PNEUMONIA, DYSPNOEA, BRONCHITIS, CENTRAL VENOUS CATHETERIZATION, GASTROSTOMY, AND HYPERBILIRUBINAEMIA. THE SUBJECT'S CONCURRENT CONDITIONS INCLUDED: ASTHMA, EPILEPSY, FEEDING TUBE USER, LENNOX-GASTAUT SYNDROME, DEVELOPMENTAL DELAY, SLEEP DISORDER, AND NEURONAL CEROID LIPOFUSCINOSIS. NO ALLERGIES WERE REPORTED. CONCOMITANT MEDICATION INCLUDED: SALBUTAMOL, ZONISAMIDE, MIDAZOLAM, CLOBAZAM, PARACETAMOL, LIDOCAINE, DIAZEPAM, MELATONIN, CETIRIZINE. PREMEDICATION INCLUDED: PARACETAMOL, LIDOCAINE, AND CETIRIZINE." "ON (B)(6) 2019, THE SUBJECT UNDERWENT IMPLANTATION OF AN INTRACEREBRAL VENTRICULOSTOMY (ICV) SET (RICKHAM; MODEL 82-1625). THE LOT NUMBER FOR THE ICV DEVICE WAS 192788. THE CATALOGUE NUMBER WAS REPORTED AS 821625. 'ON (B)(6) 2019, THE SUBJECT INITIATED TREATMENT WITH BRINEURA (300 MILLIGRAM, QOW, ICV). THE LOT NUMBER FOR BRINEURA WAS UNKNOWN. THE MOST RECENT DOSE WAS ADMINISTERED ON (B)(6)2022." "ON (B)(6) 2022, THE SUBJECT EXPERIENCED A GRADE 2 RICKHAM PORT LEAK (DEVICE LEAKAGE). NO LABORATORY OR DIAGNOSTIC TESTS WERE REPORTED. NO TREATMENT FOR THE EVENT WAS REPORTED. NO ACTION WAS TAKEN WITH BRINEURA DUE TO THE EVENT. THE OUTCOME OF THE EVENT WAS REPORTED AS UNKNOWN. THE INVESTIGATOR ASSESSED THE EVENT OF DEVICE LEAKAGE AS NOT RELATED TO TREATMENT WITH BRINEURA. THE INVESTIGATOR ASSESSED THE EVENT OF DEVICE LEAKAGE AS RELATED TO THE ICV DEVICE. ACCORDING TO THE INVESTIGATOR, OTHER ETIOLOGICAL FACTORS INCLUDED THE RICKHAM. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND, IF RECEIVED, THE REPORT WILL BE UPDATED." ADDITIONAL INFORMATION WAS RECEIVED ON 17-JUN-2022: "THE OUTCOME OF THE EVENT WAS UPDATED FROM UNKNOWN TO RECOVERED/RESOLVED WITH SEQUELAE ON (B)(6) 2022. NO FURTHER INFORMATION WAS AVAILABLE." ADDITIONAL INFORMATION RECEIVED ON 07-JUL-2022: "THE FOLLOWING INFORMATION WAS PROVIDED BY A CONSUMER. ON AN UNREPORTED DATE IN (B)(6)2022, THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR 10 DAYS BUT RECEIVED TREATMENT WITH BRINEURA AND HAD A LEAK AFTERWARDS. SHE REQUIRED SUTURES AND ENDED UP MISSING 2 DOSES OF BRINEURA. ON AN UNREPORTED DATE IN (B)(6) 2022, THE SUBJECT WAS READMITTED FOR 7 DAYS AND UNDERWENT PORTACATH REPLACEMENT SURGERY. ON (B)(6) 2022, SHE RECEIVED TREATMENT WITH BRINEURA. ON (B)(6) 2022, SHE RECEIVED ANOTHER DOSE OF BRINEURA. NO FURTHER INFORMATION WAS AVAILABLE." ADDITIONAL INFORMATION RECEIVED ON 26-NOV-2023: "THE SUBJECT'S PAST MEDICAL HISTORY INCLUDED: COUGH. CONCOMITANT MEDICATION INCLUDED: PREDNISOLONE AND DEXTROMETHORPHAN HYDROBROMIDE. TREATMENT FOR THE EVENT INCLUDED VANCOMYCIN HYDROCHLORIDE, METRONIDAZOLE HYDROCHLORIDE, METHYLPREDNISOLONE SODIUM SUCCINATE, CEFTRIAXONE SODIUM, AZITHROMYCIN, CLINDAMYCIN PHOSPHATE, AND CEFDINIR. BIOMARIN HAS ASSESSED THE EVENT AS MEDICALLY SIGNIFICANT. NO FURTHER INFORMATION WAS AVAILABLE." CASE COMMENT: "THE PATIENT EXPERIENCED DEVICE LEAKAGE, WHICH IS A KNOWN COMPLICATION OF ICV DEVICE USE. THE CAUSALITY OF DEVICE LEAKAGE IS ASSESSED AS NOT RELATED TO BRINEURA."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    98357 VENT RES TR SAL-RIC ST BA RESERVOIRS JXG INTEGRA LIFESCIENCES MANSFIELD 192788

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR Female ACETAMINOPHEN (ACETAMINOPHEN)| ALBUTEROL (ALBUTEROL)| CLOBAZAM (CLOBAZAM)| DELSYM (DEXTROMETHORPHAN HYDROBROMIDE)| LIDOCAINE (LIDOCAINE HYDROCHLORIDE)| LIDOCAINE (LIDOCAINE)| MELATONIN (MELATONIN)| MIDAZOLAM (MIDAZOLAM)| PREDNISOLONE (PREDNISOLONE SODIUM PHOSPHATE)| VALTOCO (DIAZEPAM)| ZONISAMIDE (ZONISAMIDE)