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

Model Number	82-1617
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Swelling/ Edema (4577)
Date of Event	04/27/2021
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: to treat patient's underlying disease (cln2-late infantile neuronal ceroid lipofuscinosis type 2), the patient received intraventricular enzyme therapy every 14 days via an implanted rickham reservoir (821617).The reservoir was implanted on (b)(6) 2020.On (b)(6) 2021, there were repeated swellings in the face and wet bandages after the enzyme therapy, therefore, the reservoir was replaced on (b)(6) 2021.Patient left the clinic on (b)(6) 2021 without any issue.
Additional Manufacturer Narrative
Complaint sample 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.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.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Additional information received: on (b)(6) 2014, the patient initiated treatment with brineura for the indication of neuronal ceroid lipofucinosis on (b)(6) 2020: the patient underwent implantation of rickham reservoir.In 2020, following implantation of the replacement reservoir, the patient began to experience repeated swelling of the face and wet dressings following brineura therapy on (b)(6) 2021 the faulty reservoir was removed and a replacement device was implanted.Since the device replacement there was no issue.The outcome of the event was reported as resolved.
Event or Problem Description
N/a.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Additional information received: the reporter's assessment of the event of swelling face was updated from not reported to unknown in relation to treatment with brineura.No other etiological factors were reported.No further information was available.Case comment: the patient experienced repeated swelling of the face and wet dressings are related to icv device and got resolved after icv device replacement.The causality of events are 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: 13860796
• Report Number: 3013886523-2022-00098
• Device Sequence Number: 12086174
• 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 Implanted Year: 2020
• 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: 4403106
• 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: 04/12/2022; 04/26/2022; 07/22/2022
• Initial Report FDA Received Date: 03/23/2022
• Supplement Report FDA Received Date: 04/19/2022; 05/18/2022; 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: 10 YR
• Patient Sex: Female
• Patient Weight: 30 KG