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Adverse-event reports (MAUDE)

Read this first: MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line shows reporting volume for the average device in the same FDA product code — a reporting baseline, not a risk measure.

No adverse-event reports are linked to this device.

Recall history
InitiatedRecall #ClassStatusReasonQuantityLink basis
2020-06-23Z-2884-2020Class IITerminatedReports that manipulation of the cable which connects the pre-amplifier to the nerve monitor, and the cable which connects the pre-amplifier to the stimulator pod, may cause damage to the internal construction of the cables.Distribution: Domestic: MN International: UK, Republic of Ireland, Spain, Netherlands, Canada. (Technomed Europe distributed to: Brazil, Spain, Belgium, Chile, Greece, Poland, New Zealand, Pakistan, Portugal and Thailand.49 devicesclearance family
Regulatory clearances
  • 510(k)K181559Substantially equivalent (SESE) · 2018-11-09clearance family

Predicate lineage

Cited as predicate by: K203684

Lineage each submission cites, walked transitively (indented = the cited device's own predicates). Extracted from public 510(k) summary text — heuristic, and includes reference devices mentioned alongside true predicates.

Manufacturer compliance record
DateTypeOutcomeFacilityCitations
2016-06-17VAIVoluntary action indicatedMagstim Inc3
2015-04-30VAIVoluntary action indicatedThe Magstim Company Limited0
2015-04-30VAIVoluntary action indicatedThe Magstim Company Limited0
2015-03-27VAIVoluntary action indicatedMagstim Inc2
2010-08-12VAIVoluntary action indicatedMagstim Inc1
2010-08-12VAIVoluntary action indicatedMagstim Inc1
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