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Prometra Patient Therapy Controller
Flowonix Medical, Inc. · Model 12860 · UDI-DI 00810335020174
LKK
Prescription
0
510(k) clearances
117,224
Adverse events (1,634 deaths)
132
Recalls
19
Facilities
Description
The Patient Therapy Controller (PTC) is a handheld touchscreen device, which allows a patient to initiate a pre-configured supplemental bolus of medication from their implanted Programmable Pump. The patient requests a bolus by pressing the Rx button on the PTC and then placing it over their implanted pump. The Patient Therapy Controller communicates with the implanted pump initiating the supplemental bolus delivery. The settings for the bolus delivery are programmed into the Patient Therapy Controller by a healthcare certified professional (HCP) using the Configuration Device.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-05-11 | Boston Scientific Corporation | There is the potential for leakage along the drug pathway from the pump through the end of the catheter. |
| 2026-04-08 | Medtronic Neuromodulation | Software issue: When programming the SynchroMed Pump with the A810 CP App in Flex Infusion Mode, the infusion steps should automatically be arranged in consecutive order, from ear |
| 2025-01-09 | Medtronic Neuromodulation | Product complaints were received describing the A820 myPTM app taking longer than expected for patients to interact with their implantable pump. |
| 2024-11-21 | Medtronic Neuromodulation | Software issues were identified in application version 2.x. |
| 2024-11-21 | Medtronic Neuromodulation | Software issues were identified in application version 2.x. |
| 2024-11-21 | Medtronic Neuromodulation | Software issues were identified in application version 2.x. |
| 2024-11-21 | Medtronic Neuromodulation | Software issues were identified in application version 2.x. |
| 2024-09-11 | Medtronic Neuromodulation | Potential for error and inability to interrogate pump due to data corruption in the pump memory. |
| 2024-05-10 | Medtronic Neuromodulation | Design update to the Ascenda Intrathecal Catheter Models 8780, 8781, and 8784. The intent of the design update is to reduce the potential for tissue growth into the Ascenda cathet |
| 2023-11-13 | Medtronic Neuromodulation | Medtronic recently identified that if the SynchroMed II pump switches into telemetry mode due to electromagnetic interference (EMI) from an MRI scan, while the pump is sounding an |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.