MAUDE Adverse Event Report: ALGORITHM SCIENCES, INC. PROMETRA II PROGRAMMABLE PUMP; IMPLANTABLE INFUSION PUMP

Model Number	13827
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/25/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of the device history record, which includes verification of all steps in the manufacturing of the pump, verification of all final testing performed by/on the pump, verification of sterilization, and packaging for subject pump was performed.The review did not identify any nonconformances, issues or capas associated with pump function.Device was not returned for additional evaluation and investigation.As additional physical investigation was not performed on the device, a definitive root cause could not be determined for the alleged issue.Several attempts were made to follow up with the physician's office to retrieve information on patient status and to confirm details regarding the issue, but these attempts were unsuccessful.Internal complaint number: (b)(4).
Event or Problem Description
Physician contacted technical solutions reporting a patient that was admitted to the hospital.Technical solutions asked the physician if the patient was hospitalized due to an alleged overmedication or undermedication.The physician reported that the patient had gone to a small rural hospital and were unable to determine the cause.The physician reported that the hospital had administered several doses of narcan to "little effect", and the patient was kept overnight for observation.The patient was discharged the next morning.The physician reported that the patient would be visiting their office for a follow-up appointment.Technical solutions asked the physician to analyze the pump by performing a volume check.The physician reported that if they did not call back to technical solutions, it was because the physician deemed the pump as functioning correctly and no further assistance from technical solutions would be required.

• Brand Name: PROMETRA II PROGRAMMABLE PUMP
• Common Device Name: IMPLANTABLE INFUSION PUMP
• Manufacturer (Section D): ALGORITHM SCIENCES, INC.; 500 international drive; suite 200; mount olive NJ 07828
• Manufacturer (Section G): ALGORITHM SCIENCES, INC.; 120 forbes blvd; suite 170; mansfield MA 02048
• Manufacturer Contact: nicholas ranalli ; 500 international drive; suite 200; mount olive, NJ 07828 ; 8459019335
• MDR Report Key: 17174992
• Report Number: 3010079947-2023-00052
• Device Sequence Number: 14772594
• Product Code: LKK
• UDI-Device Identifier: 00810335020228
• UDI-Public: (01)00810335020228(17)190208(10)24572
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P080012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/26/2023

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: 02/08/2019
• Device Model Number: 13827
• Device Catalogue Number: 13827
• Device Lot Number: 24572
• 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: 05/26/2023
• Initial Report FDA Received Date: 06/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/08/2018
• 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: Hospitalization
• Patient Sex: Female