MAUDE Adverse Event Report: FLOWONIX MEDICAL, INC. PROMETRA PROGRAMMABLE PUMP; IMPLANTABLE INFUSION PUMP

Model Number	11827
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Muscle Spasm(s) (1966); Sleep Dysfunction (2517); Cramp(s) /Muscle Spasm(s) (4521)
Date of Event	06/30/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending review of dhr and further follow-up.Internal complaint number: (b)(4).
Event or Problem Description
Patient tracking contacted technical solutions in order to report a prometra pump replacement.It was reported that the patient was having symptoms such as insomnia and increased spasticity.A side port study as well as a valve and reservoir check were performed.All showed the pump and catheter were functioning properly.It was stated that the patient's medication could have been what was causing the symptoms.Symptoms persisted, and the pump was replaced to eliminate the possibility of it being the cause.
Additional Manufacturer Narrative
Device was not returned for additional evaluation or investigation.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, and packaging for subject pump was performed.The review did not identify any non-conformances, issues or capas associated with pump function.A supplemental mdr will be submitted if/when new information is received.Internal complaint number: (b)(4).

• Brand Name: PROMETRA PROGRAMMABLE PUMP
• Common Device Name: IMPLANTABLE INFUSION PUMP
• Manufacturer (Section D): FLOWONIX MEDICAL, INC.; 500 international drive; suite 200; mount olive, nj
• MDR Report Key: 10477328
• Report Number: 3010079947-2020-00278
• Device Sequence Number: 3120229
• Product Code: LKK
• UDI-Device Identifier: 00810335020082
• UDI-Public: (01)00810335020082(10)20230(17)170319
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P080012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/30/2020

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: 03/19/2017
• Device Model Number: 11827
• Device Catalogue Number: 11827
• Device Lot Number: 20230
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/30/2020
• Supplement Date Received by Manufacturer: 09/01/2020
• Initial Report FDA Received Date: 09/01/2020
• Supplement Report FDA Received Date: 10/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention