Medtronic SynchroMed II, Model 8637-20, Programmable pump

FDA device recall Z-0614-2024 · posted 2023-12-22 · Open, Classified

Recall details

Recalling firm

Medtronic Neuromodulation

Reason for recall

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.

Action taken

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 at www.manuals.medtronic.com). . Remind your patients about the importance of interrogating the SynchroMed II pump after an MRI to ensure continuation of therapy. . Educate patients, caregivers, and family members to recognize the signs and symptoms associated with intrathecal drug therapy underdose or withdrawal. Patients receiving intrathecal baclofen therapy (e.g., Lioresal Intrathecal) are at higher risk for adverse events, as baclofen withdrawal can lead to a life-threatening condition if not treated promptly and effectively. For questions or concerns associated with this correction, please contact your Medtronic Representative or Technical Services at 1-800-707-0933. On 07/10/2024, Medtronic sent an additional notification to customers to correct an error in the previous communication. The previous communication incorrectly included a reference to the use of the Patient Therapy Manager as part of the recommended mitigations. The updated communication has been revised to remove reference to the Patient Therapy Manager. All other aspects of the mitigations remain unchanged.

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

LKK

Quantity affected

98311 units

Distribution

Worldwide

Date initiated

2023-11-13

Date posted

2023-12-22

Location

Minneapolis, MN