Model Number 82-1617 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Swelling/ Edema (4577)
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Event Date 04/27/2021 |
Event Type
Injury
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Manufacturer Narrative
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An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.
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Event Description
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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.
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Manufacturer Narrative
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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.
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Event Description
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N/a.
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Manufacturer Narrative
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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.
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Event Description
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N/a.
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Event Description
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N/a.
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Manufacturer Narrative
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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.
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Search Alerts/Recalls
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