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	Cramp(s) /Muscle Spasm(s) (4521)
Date of Event	12/14/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient tracking received a replacement tracking form through email reporting a pump system replacement.Additional follow up will be performed to determine the reason for replacement.Nurse confirmed that the patient's pump system was explanted due to unrelieved spasticity as well as past underinfusion volume discrepancies.
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.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: 18466457
• Report Number: 3030198397-2024-00001
• Device Sequence Number: 14231815
• Product Code: LKK
• UDI-Device Identifier: 00810335020228
• UDI-Public: (01)00810335020228(17)210723(10)26665
• 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: 2020
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/08/2024

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: 07/23/2021
• Device Model Number: 13827
• Device Catalogue Number: 13827
• Device Lot Number: 26665
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/14/2023
• Initial Report FDA Received Date: 01/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/23/2020
• 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: Female