MAUDE Adverse Event Report: Intera Oncology INTERA; Pump, Infusion, Implanted, Programmable

Model Number	AP-03000H
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Seroma (2069)
Date of Event	07/17/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient developed seroma.The physician contacted boston scientific to request information regarding the management of the seroma.The seroma was identified during a postoperative follow-up visit approximately three weeks after the implant procedure.The patient had a history of atrial fibrillation and was receiving eliquis (apixaban), which was reported as a medical condition and concomitant medication.Additional medications included atenolol, dorzolamide, latanoprost, and bumex.The fluid collection was located directly over the intera 3000 hai pump and presented as painless swelling without redness.The seroma was diagnosed based on physical examination only; no imaging studies were performed.The estimated fluid volume was approximately 50 ml, and the fluid was reported to be slightly bloody.The pump was not explanted or replaced.At the time of reporting, no recurrence of the seroma had been observed.
Additional Manufacturer Narrative
We are unable to provide the unique identifier (udi) # for this product.All available product data has been included in this report.Boston scientific is conducting an investigation to identify further product details.If further product details are identified, a supplemental report will be submitted.

• Brand Name: INTERA
• Common Device Name: Pump, Infusion, Implanted, Programmable
• Manufacturer (Section D): Intera Oncology; 180 wells avenue, ste 300a; newton MA 02459
• Manufacturer (Section G): Boston Scientific Corporation; 180 wells avenue; suite 300a; newton MA 02459
• Manufacturer Contact: ricardo amaro castro ; 4100 hamline ave n; arden hills, MN 55112 ; +1(952)930-6396
• MDR Report Key: 50256092
• Report Number: 2124215-2026-43698
• Device Sequence Number: 10246733
• Product Code: LKK
• UDI-Device Identifier: 00850014110147
• UDI-Public: (01)00850014110147
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/14/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: AP-03000H
• Device Catalogue Number: AP03000H
• Device Lot Number: 32818639
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/17/2026
• Initial Report FDA Received Date: 08/14/2026
• Date Device Manufactured: 01/06/2026
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown