The Recall Desk
HighFDA (Devices)·Z-0614-2024·Announced 2024-01-03

Medtronic SynchroMed II Pump May Fail to Resume Drug Delivery After MRI

The Medtronic SynchroMed II pump may fail to resume drug delivery after MRI if electromagnetic interference triggers telemetry mode while the pump is alarming. This could interrupt essential medication delivery in patients.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II medical device with theoretical risk of treatment interruption but no reported hospitalizations or injuries. The hazard is conditional and specific (EMI exposure during MRI while alarming), affecting a risk-of-harm product (drug delivery pump for essential medications).

Plain-English summary

The Medtronic SynchroMed II Model 8637-20 is a programmable implantable pump used to deliver medication directly into the spinal cord. It is designed for patients requiring continuous drug infusion for conditions such as chronic pain and spasticity. Approximately 98,311 units have been distributed worldwide.

Medtronic has identified a device malfunction that may occur under specific circumstances. If the pump is exposed to electromagnetic interference (EMI) from an MRI scan while the pump is actively sounding an alarm, the pump may enter telemetry mode. When this occurs, the pump will not automatically resume normal drug delivery after the patient leaves the MRI's magnetic field. This represents a deviation from the device's intended behavior as described in current labeling.

Patients with a SynchroMed II pump should discuss this issue with their healthcare provider, especially if they anticipate needing an MRI scan. Healthcare providers should review the updated device information and establish any necessary precautions for patients who require MRI procedures. Medtronic has identified specific serial numbers associated with this issue; patients and healthcare providers should contact Medtronic or refer to the FDA recall notification (Z-0614-2024) to determine if a particular device is affected.

The recalled product

Product
Medtronic SynchroMed II, Model 8637-20, Programmable pump
Manufacturer
Medtronic Neuromodulation
Category
Medical Device — Implantable Drug Delivery Pump
Hazard
Affected units
98,311

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • GTIN 00613994518781
  • Serial Numbers: NGP756746H
  • NGP000266H
  • NGP000270H
  • NGP000273H
  • NGP000274H
  • NGP000276H
  • NGP000292H
  • NGP000293H
  • NGP000312H
  • NGP000513H
  • NGP000515H
  • NGP000516H
  • NGP000589H
  • NGP000591H
  • NGP000592H
  • NGP000595H
  • NGP000596H
  • NGP000597H
  • NGP000598H

Distribution

Distribution scope not specified by the agency.

Part of a larger recall action

This product is one of 2 recalled by Medtronic Neuromodulation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Related recalls

Same manufacturer · Medtronic Neuromodulation

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Same hazard · electromagnetic interference

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