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	Unspecified Infection (1930)
Date of Event	09/01/2026
Type of Reportable Event	Serious Injury

• 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): MEDICAL DEVICE INTERMEDIATE INC; 110 forbes blvd; mansfield MA 02048
• Manufacturer Contact: ricardo amaro castro ; 4100 hamline ave n; arden hills, MN 55112 ; +1(952)930-6396
• MDR Report Key: 50916728
• Report Number: 2124215-2026-51426
• Device Sequence Number: 12148764
• Product Code: LKK
• UDI-Device Identifier: 00850014110147
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: P890055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/28/2026

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 Expiration Date: 09/30/2025
• Device Model Number: AP-03000H
• Device Catalogue Number: AP03000H
• Device Lot Number: 0000018629
• 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: 09/01/2026
• Initial Report FDA Received Date: 09/28/2026
• Date Device Manufactured: 05/30/2024
• 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: Required Intervention
• Patient Age: 63 YR
• Patient Sex: Unknown