Recall Z-0614-2024 ยท LKK Pump, Infusion, Implanted, Programmable
Medtronic Neuromodulation
Medtronic SynchroMed II, Model 8637-20, Programmable pump
| Date | Dec 22, 2023 (initiated Nov 13, 2023) |
| Status | Open, Classified |
| Reason | 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 alarm, the pump will not resume drug delivery after leaving the MRI magnetic field, which is inconsistent with the current labeling. |
| Root cause | Under Investigation by firm |
| Action | Medtronic issued an URGENT MEDICAL DEVICE CORRECTION notice to healthcare providers and medical facilities on 77/13/2023 via mail and email. The notice explained the problem with the device, hazards to patient, and recommended the following: Patient Management Recommendations: . Upon completion of an MRI scan, interrogate the pump with the Clinician Programmer (or Personal Therapy Manager) to end telemetry mode and resume drug delivery. . Consult the MRI Guidelines for additional information on MRI preparation and post-examination review, and motor stall recovery timing (see MRI Guidelines |
| Quantity | 98311 units |
| Distribution | Worldwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.