MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR HOLTER SALMON RICKHAM LP; RESERVOIRS

Model Number	82-1617
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Bacterial Infection (1735); Fatigue (1849); Fever (1858)
Date of Event	10/23/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.
Event or Problem Description
Study; patient receives intraventricular enzyme therapy every 14 days via rickham reservoir.After the intraventruicular therapy on (b)(6) 2021, patient presented with fever and increasing tiredness on (b)(6) 2021.In a sample from (b)(6) 2021 before intraventricular therapy, staph capitis was detected; therefore, rickham reservoir was explanted on (b)(6) 2021 following antibiotic therapy for 14 days and replacement of the rickham reservoir on (b)(6) 2021.Patient recovered.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Rickham reservoir was not returned for evaluation (discarded); 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; however, the possible root cause for the ¿fever and increasing tiredness" reported by the customer, could be linked to the patient and hospital surroundings as the review of the sterilization certificate was conform to specifications when released.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
Additional information received: in 2018, the patient initiated treatment with brineura for the indication of neuronal ceroid lipofuscinosis the most recent dose was administered on (b)(6) 2021.On (b)(6) 2021, prior receiving brineura, a cerebral spinal fluid culture was taken.The result of csf culture was positive for staph.Capitalis.On (b)(6) 2021, she was hospitalized due to encephalitis.Symptoms included fewer and increasing fatigue.On the same day, the reservoir was removed and she was treated with unspecified antibiotics for 14 days.On unreported date, the treatment with brineura was temporarily held.The outcome of event was reported as resolved.
Additional Manufacturer Narrative
Additional information received: the reporter assessed the event of encephalitis as unknown in relation to treatment with brineura.No other etiological factors were reported.No further information was available.Case comment: the patient experienced encephalitis which is a known complication of icv device use.The causality of event is assessed as not related to brineura.

• Brand Name: HOLTER SALMON RICKHAM LP
• Common Device Name: RESERVOIRS
• Manufacturer (Section D): INTEGRA LIFESCIENCES SWITZERLAND SAR; rue girardet 29; rue girardet 29; le locle ; SZ
• Manufacturer (Section G): INTEGRA LIFESCIENCES SWITZERLAND SAR; rue girardet 29; ch-2400; le locle ; SZ
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 13862050
• Report Number: 3013886523-2022-00102
• Device Sequence Number: 4666631
• Product Code: JXG
• UDI-Device Identifier: 10886704040477
• UDI-Public: (01)10886704040477(17)241231(10)4403106
• Combination Product (Y/N): N
• PMA/510(K) Number: K102961
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Study
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 08/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2024
• Device Model Number: 82-1617
• Device Catalogue Number: 821617
• Device Lot Number: 2004547
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/03/2022
• Supplement Date Received by Manufacturer: 04/26/2022; 06/01/2022; 07/21/2022
• Initial Report FDA Received Date: 03/23/2022
• Supplement Report FDA Received Date: 05/18/2022; 06/08/2022; 08/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/27/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 8 YR
• Patient Sex: Female
• Patient Weight: 22 KG