VENT RES TR SAL-RIC ST BA
Report
- Report Number
- 3013886523-2021-00492
- Event Type
- Injury
- Date Received
- November 17, 2021
- Date of Event
- September 28, 2017
- Report Date
- February 23, 2022
- Manufacturer
- INTEGRA LIFESCIENCES MANSFIELD
- Product Code
- JXG
- PMA / PMN Number
- K102961
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.
AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.
COMPLAINT SAMPLE WAS NOT RETURNED FOR EVALUATION; THEREFORE, AN EVALUATION OF THE DEVICE COULD NOT BE PERFORMED. LOT NUMBER INFORMATION HAS BEEN PROVIDED; THEREFORE, MANUFACTURING RECORDS WERE REVIEWED AND FOUND NO ANOMALIES. THE CAUSE(S) OF THE DIFFICULTY REPORTED BY THE CUSTOMER COULD NOT BE DETERMINED. 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. A MEDICAL ASSESSMENT WAS REQUESTED AND THE FOLLOWING WAS CONCLUDED: REGARDING THE SECOND REVISION DESCRIBED AS THE SHUNT MALFUNCTION OR ¿NOT WORKING¿ MAY HAVE A POSSIBLE RELATIONSHIP TO THE DEVICE. SINCE THE DEVICE WAS NOT RETURNED FOR INVESTIGATION A DEFINITIVE DETERMINATION OF THE CAUSAL RELATIONSHIP TO THE DEVICE CANNOT BE MADE.
1 OF 2 REPORTS. OTHER MFG REPORT NUMBER: 3013886523-2021-0049 STUDY: "A MULTICENTER, MULTINATIONAL, EXTENSION STUDY TO EVALUATE THE LONG-TERM EFFICACY AND SAFETY OF BMN 190 IN PATIENTS WITH CLN2 DISEASE." ON (B)(6) 2016, A (B)(6) MALE PATIENT UNDERWENT IMPLANTATION WITH AN INTRACEREBROVENTRICULAR DEVICE (ICV) SET (CODMAN SHURTLEFF ICV DEVICE; SERIAL #(B)(4), MODEL NUMBER UNREPORTED) LOT CVCB4B. ON (B)(6) 2015, THE SUBJECT INITIATED TREATMENT WITH BMN 190 (375 MG, QOW, INTRACISTERNAL). ON (B)(6) 2017, A CSF CULTURE WAS TAKEN FROM THE SUBJECT'S ICV DEVICE. THE SUBJECT'S CSF CULTURE SHOWED AN INCREASED WHITE CELL COUNT BUT NO ORGANISMS ON MICROSCOPY. FROM 11:01 TO 15:11, THE SUBJECT RECEIVED HIS BMN 190 INFUSION. ON (B)(6) 2017 AT 07:38, WITHIN 24 HOURS, THE SUBJECT EXPERIENCED A GRADE TWO PYREXIA (PYREXIA) WITH A MAXIMUM TEMPERATURE OF 38.4°C. SUBSEQUENTLY, THE SUBJECT VOMITED THREE TIMES WITH AN UNSPECIFIED TEMPERATURE. AT AN UNREPORTED TIME, THE SUBJECT TOOK PARACETAMOL AND IBUPROFEN, ATE AND DRANK, AND HAD NO FURTHER VOMITING EPISODES. ON (B)(6) 2017, THE SUBJECT'S CEREBROSPINAL FLUID (CSF) WHITE BLOOD CELL COUNT WAS INCREASED WITH NO ORGANISMS NOTED ON MICROSCOPY. ON AN UNREPORTED DATE, THE SUBJECT WAS DISCHARGED HOME. AFTER DISCHARGE, THE SUBJECT'S CSF CULTURE SHOWED STREPTOCOCCUS WITH POSSIBLE CONTAMINANT. A REPEAT OF CSF SAMPLE WAS RECOMMENDED AND PLANNED. NO ADDITIONAL LABORATORY OR DIAGNOSTIC TESTS WERE REPORTED. NO ADDITIONAL TREATMENT FOR THE EVENT WAS REPORTED. NO ACTION WAS TAKEN WITH BMN 190 DUE TO THE EVENT. THE SUBJECT REMAINED WELL. HE WAS ADMINISTERED HIS BMN INFUSION AND A SECOND CSF SAMPLE WAS OBTAINED. THE CSF SAMPLE APPEARED CLEAR. THE SUBJECT'S CSF WHITE CELL COUNT WAS 15X10^6/L, PROTEIN AND GLUCOSE WERE NORMAL AND NO ORGANISMS SEEN UPON MICROSCOPY. ON AN UNREPORTED DATE, MICROBIOLOGY INFORMED THAT THE CSF SAMPLE WAS GROWING STREPTOCOCCUS VIRIDANS (ORALIS) AGAIN. MICROBIOLOGY ADVISED THAT ALTHOUGH THIS ORGANISM WAS LESS VIRULENT, THE DEVICE NEEDED TO BE REMOVED AND THEN TO ADMINISTER INTRAVENOUS CEFTRIAXONE FOR 10-14 DAYS BEFORE ANOTHER DEVICE IS INSERTED. THE SUBJECT WAS SUBSEQUENTLY HOSPITALIZED, AND THEY WERE WAITING FOR NEUROSURGEONS TO BE AVAILABLE TO PROCEED WITH THE DEVICE REMOVAL. THE ACTION TAKEN WITH BMN 190 DUE TO THE EVENT WAS UPDATED FROM NO CHANGE TO TREATMENT HELD ON AN UNREPORTED DATE. THE OUTCOME OF THE EVENT WAS REPORTED AS RECOVERING/RESOLVING. THE INVESTIGATOR ASSESSED THE EVENT AS MEDICALLY SIGNIFICANT. THE INVESTIGATOR ASSESSED THE EVENT OF DEVICE RELATED INFECTION AS NOT RELATED TO TREATMENT WITH BMN 190. THE INVESTIGATOR ASSESSED THE EVENT OF INFECTION AS RELATED TO THE ICV DEVICE. IN THE INVESTIGATOR'S OPINION, OTHER ETIOLOGICAL FACTORS INCLUDED A DEVICE THE OUTCOME OF THE EVENT WAS REPORTED AS RECOVERING/RESOLVING. ON AN UNREPORTED DATE, THE SUBJECT WAS WELL AND HAD NO CONCERNS. THE INVESTIGATOR ASSESSED THE EVENT OF PYREXIA AS RELATED TO TREATMENT WITH BMN 190. IN THE INVESTIGATOR'S OPINION, OTHER ETIOLOGICAL FACTORS INCLUDED THE SUBJECT WAS POSSIBLY STARTING TO DEVELOP AN INFECTION. ON (B)(6) 2017, THE ICV DEVICE WAS REMOVED. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2017: ON AN UNREPORTED DATE, THE SUBJECT REMAINED CLINICALLY WELL WITHOUT ANY PHYSICAL EXAM FINDINGS OF MENINGITIS. SUBSEQUENTLY, THE EVENT WAS CONSIDERED A DEVICE INFECTION, BUT NOT MENINGITIS. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2017: FROM 28-SEP-2017 TO 07-OCT-2017, TREATMENT FOR THE EVENT INCLUDED CEFTRIAXONE. ON (B)(6) 2017, THE SUBJECT UNDERWENT IMPLANTATION WITH A NEW INTRACEREBROVENTRICULAR DEVICE (ICV) SET (CODMAN SHURTLEFF ICV DEVICE; SERIAL # (B)(4), MODEL NUMBER UNREPORTED, REF 82-1625, LOT # 131335. THE OUTCOME OF THE EVENT WAS UPDATED FROM RECOVERING/RESOLVING TO RECOVERED/RESOLVED ON (B)(6) 2017 AT 16:30. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2017: IT WAS REPORTED THAT THE NEWLY IMPLANTED ICV DEVICE WAS NOT WORKING AND WOULD BE REPLACED (REF # (B)(4)). ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2021: FOLLOW UP INFORMATION FOR THIS CASE WAS RECEIVED BY A PHYSICIAN FROM A LITERATURE ARTICLE. IT WAS REPORTED THAT THE SUBJECT REQUIRED MULTIPLE REVISIONS DUE TO AN INITIAL CSF LEAK THAT RESULTED IN BACTERIAL GROWTH IN THE CSF CULTURE, EVEN THOUGH THE RESERVOIR WAS CHANGED. SUBSEQUENTLY, THE SUBJECT'S VENTRICULAR CATHETER BECAME BLOCKED. CASE COMMENT: INFECTION IS A KNOWN RISK FACTOR OF ICV DEVICES. THE EVENT IS LIKELY DUE TO BACTERIAL INFECTION WITH STREPTOCOCCUS VIRIDIANS AND IS NOT SUSPECTED TO BE RELATED TO BMN 190.
1 OF 2 REPORTS. OTHER MFG REPORT NUMBER: 3013886523-2021-0049 STUDY: "A MULTICENTER, MULTINATIONAL, EXTENSION STUDY TO EVALUATE THE LONG-TERM EFFICACY AND SAFETY OF BMN 190 IN PATIENTS WITH CLN2 DISEASE." ON (B)(6) 2016, A (B)(6) MALE PATIENT UNDERWENT IMPLANTATION WITH AN INTRACEREBROVENTRICULAR DEVICE (ICV) SET (CODMAN SHURTLEFF ICV DEVICE; SERIAL #(B)(6), MODEL NUMBER UNREPORTED) LOT CVCB4B. ON (B)(6) 2015, THE SUBJECT INITIATED TREATMENT WITH BMN 190 (375 MG, QOW, INTRACISTERNAL). ON (B)(6) 2017, A CSF CULTURE WAS TAKEN FROM THE SUBJECT'S ICV DEVICE. THE SUBJECT'S CSF CULTURE SHOWED AN INCREASED WHITE CELL COUNT BUT NO ORGANISMS ON MICROSCOPY. FROM 11:01 TO 15:11, THE SUBJECT RECEIVED HIS BMN 190 INFUSION. ON (B)(6) 2017 AT 07:38, WITHIN 24 HOURS, THE SUBJECT EXPERIENCED A GRADE TWO PYREXIA (PYREXIA) WITH A MAXIMUM TEMPERATURE OF 38.4°C. SUBSEQUENTLY, THE SUBJECT VOMITED THREE TIMES WITH AN UNSPECIFIED TEMPERATURE. AT AN UNREPORTED TIME, THE SUBJECT TOOK PARACETAMOL AND IBUPROFEN, ATE AND DRANK, AND HAD NO FURTHER VOMITING EPISODES. ON (B)(6) 2017, THE SUBJECT'S CEREBROSPINAL FLUID (CSF) WHITE BLOOD CELL COUNT WAS INCREASED WITH NO ORGANISMS NOTED ON MICROSCOPY. ON AN UNREPORTED DATE, THE SUBJECT WAS DISCHARGED HOME. AFTER DISCHARGE, THE SUBJECT'S CSF CULTURE SHOWED STREPTOCOCCUS WITH POSSIBLE CONTAMINANT. A REPEAT OF CSF SAMPLE WAS RECOMMENDED AND PLANNED. NO ADDITIONAL LABORATORY OR DIAGNOSTIC TESTS WERE REPORTED. NO ADDITIONAL TREATMENT FOR THE EVENT WAS REPORTED. NO ACTION WAS TAKEN WITH BMN 190 DUE TO THE EVENT. THE SUBJECT REMAINED WELL. HE WAS ADMINISTERED HIS BMN INFUSION AND A SECOND CSF SAMPLE WAS OBTAINED. THE CSF SAMPLE APPEARED CLEAR. THE SUBJECT'S CSF WHITE CELL COUNT WAS 15X10^6/L, PROTEIN AND GLUCOSE WERE NORMAL AND NO ORGANISMS SEEN UPON MICROSCOPY. ON AN UNREPORTED DATE, MICROBIOLOGY INFORMED THAT THE CSF SAMPLE WAS GROWING STREPTOCOCCUS VIRIDANS (ORALIS) AGAIN. MICROBIOLOGY ADVISED THAT ALTHOUGH THIS ORGANISM WAS LESS VIRULENT, THE DEVICE NEEDED TO BE REMOVED AND THEN TO ADMINISTER INTRAVENOUS CEFTRIAXONE FOR 10-14 DAYS BEFORE ANOTHER DEVICE IS INSERTED. THE SUBJECT WAS SUBSEQUENTLY HOSPITALIZED, AND THEY WERE WAITING FOR NEUROSURGEONS TO BE AVAILABLE TO PROCEED WITH THE DEVICE REMOVAL. THE ACTION TAKEN WITH BMN 190 DUE TO THE EVENT WAS UPDATED FROM NO CHANGE TO TREATMENT HELD ON AN UNREPORTED DATE. THE OUTCOME OF THE EVENT WAS REPORTED AS RECOVERING/RESOLVING. THE INVESTIGATOR ASSESSED THE EVENT AS MEDICALLY SIGNIFICANT. THE INVESTIGATOR ASSESSED THE EVENT OF DEVICE RELATED INFECTION AS NOT RELATED TO TREATMENT WITH BMN 190. THE INVESTIGATOR ASSESSED THE EVENT OF INFECTION AS RELATED TO THE ICV DEVICE. IN THE INVESTIGATOR'S OPINION, OTHER ETIOLOGICAL FACTORS INCLUDED A DEVICE THE OUTCOME OF THE EVENT WAS REPORTED AS RECOVERING/RESOLVING. ON AN UNREPORTED DATE, THE SUBJECT WAS WELL AND HAD NO CONCERNS. THE INVESTIGATOR ASSESSED THE EVENT OF PYREXIA AS RELATED TO TREATMENT WITH BMN 190. IN THE INVESTIGATOR'S OPINION, OTHER ETIOLOGICAL FACTORS INCLUDED THE SUBJECT WAS POSSIBLY STARTING TO DEVELOP AN INFECTION. ON (B)(6) 2017, THE ICV DEVICE WAS REMOVED. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2017: ON AN UNREPORTED DATE, THE SUBJECT REMAINED CLINICALLY WELL WITHOUT ANY PHYSICAL EXAM FINDINGS OF MENINGITIS. SUBSEQUENTLY, THE EVENT WAS CONSIDERED A DEVICE INFECTION, BUT NOT MENINGITIS. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2017: FROM 28-SEP-2017 TO 07-OCT-2017, TREATMENT FOR THE EVENT INCLUDED CEFTRIAXONE. ON (B)(6) 2017, THE SUBJECT UNDERWENT IMPLANTATION WITH A NEW INTRACEREBROVENTRICULAR DEVICE (ICV) SET (CODMAN SHURTLEFF ICV DEVICE; SERIAL # (17)220331(10)131335, MODEL NUMBER UNREPORTED, REF #(B)(4), LOT # 131335. THE OUTCOME OF THE EVENT WAS UPDATED FROM RECOVERING/RESOLVING TO RECOVERED/RESOLVED ON (B)(6) 2017 AT 16:30. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2017: IT WAS REPORTED THAT THE NEWLY IMPLANTED ICV DEVICE WAS NOT WORKING AND WOULD BE REPLACED (REF # (B)(4)). ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2021: FOLLOW UP INFORMATION FOR THIS CASE WAS RECEIVED BY A PHYSICIAN FROM A LITERATURE ARTICLE. IT WAS REPORTED THAT THE SUBJECT REQUIRED MULTIPLE REVISIONS DUE TO AN INITIAL CSF LEAK THAT RESULTED IN BACTERIAL GROWTH IN THE CSF CULTURE, EVEN THOUGH THE RESERVOIR WAS CHANGED. SUBSEQUENTLY, THE SUBJECT'S VENTRICULAR CATHETER BECAME BLOCKED. CASE COMMENT: INFECTION IS A KNOWN RISK FACTOR OF ICV DEVICES. THE EVENT IS LIKELY DUE TO BACTERIAL INFECTION WITH STREPTOCOCCUS VIRIDIANS AND IS NOT SUSPECTED TO BE RELATED TO BMN 190.
N/A.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1725676 | VENT RES TR SAL-RIC ST BA | RESERVOIRS | JXG | INTEGRA LIFESCIENCES MANSFIELD | 131335 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 6 YR | Male |