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

Model Number	13827
Medical Device Problem Code	Insufficient Flow or Under Infusion (2182)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	03/18/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Reporter contacted patient tracking through email reporting a pump replacement due to underinfusion volume discrepancies and the patient experiencing a decrease in pain therapy.Reporter confirmed that a catheter dye study was previously performed which confirmed that the catheter was patent.Additionally, the patient's pump was discarded after replacement.
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 non-conformances, issues or capas associated with pump function.Device was discarded and 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.Internal complaint number: (b)(4).

• Brand Name: PROMETRA II PROGRAMMABLE PUMP
• Common Device Name: IMPLANTABLE INFUSION PUMP
• Manufacturer (Section D): ALGORITHM SCIENCES, INC.; 121 shelley drive; suite 2h; hackettstown NJ 07840
• Manufacturer (Section G): ALGORITHM SCIENCES, INC.; 121 shelley drive; suite 2h; hackettstown NJ 07840
• Manufacturer Contact: nicholas ranalli ; 121 shelley drive; suite 2h; hackettstown, NJ 07840 ; 9734269229
• MDR Report Key: 18933856
• Report Number: 3030198397-2024-00007
• Device Sequence Number: 9365274
• Product Code: LKK
• UDI-Device Identifier: 00810335020228
• UDI-Public: (01)00810335020228(17)170720(11)22676
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: P080012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2024
• 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): 03/19/2024

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/20/2017
• Device Model Number: 13827
• Device Catalogue Number: 13827
• Device Lot Number: 22676
• 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: 03/18/2024
• Initial Report FDA Received Date: 03/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/20/2017
• 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 Sex: Male