Recall Z-1524-2014— Medtronic Neuromodulation

Class II FDA medical device recall by Medtronic Neuromodulation, initiated 2014-02-27, terminated 2014-11-07. FDA's recall record names no specific 510(k) clearance for this event. Product: Medtronic neurostimulators. Restore (37711), RestoreADVANCED (37713), RestoreADVANCED SureScan MRI (97713), RestoreSENSOR (37714), RestoreSENSOR SureScan MRI (97714), PrimeAdvanced SureScan MRI, (97702), RestoreULTRA (37712), RestoreULTRA SureScan MRI (97712), Itrel 4 (37703), Itrel 4 (37704), RestorePrime (37701), PrimeAdvanced (37702), Spinal Cord Stimulators for chronic pain.. Reason: Medtronic neurostimulators (used with pain and deep brain stimulation therapy) have a cycling feature that, when enabled, allows stimulation output to be toggled on and off based on the programmed settings. The use of this feature is determined by the physician and set using the clinician programmer. Current labeling indicates the use of cycling improves device longevity and recharge interval.

Recalling firm

Medtronic Neuromodulation

Classification

Class II

Status

Terminated

Initiated

2014-02-27

Terminated

2014-11-07

Firm location

Minneapolis, MN, United States

Data sourced from openFDA. This site is unofficial and independent of the FDA.