TPLC - Total Product Life Cycle

• Device: stimulator, electrical, evoked response
• Regulation Description: Evoked response electrical stimulator.
• Product Code: GWF
• Regulation Number: 882.1870
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
ALPHATEC SPINE, INC.
	SUBSTANTIALLY EQUIVALENT	2
CADWELL INDUSTRIES, INC.
	SUBSTANTIALLY EQUIVALENT	1
INOMED MEDIZINTECHNIK GMBH
	SUBSTANTIALLY EQUIVALENT	2
MEDTRONIC XOMED, INC.
	SUBSTANTIALLY EQUIVALENT	1
NATUS NEUROLOGY INCORPORATED
	SUBSTANTIALLY EQUIVALENT	2
NEUROSOFT LTD
	SUBSTANTIALLY EQUIVALENT	1
QUANTALX NEUROSCIENCE
	SUBSTANTIALLY EQUIVALENT	1
SOTERIX MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	2

MDR Year	MDR Reports	MDR Events
2020	65	65
2021	54	54
2022	45	45
2023	150	150
2024	854	854
2025	528	528

Device Problems	MDRs with this Device Problem	Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings	843	843
Use of Device Problem	254	254
Inappropriate Audible Prompt/Feedback	174	174
False Negative Result	160	160
Failure to Power Up	112	112
False Positive Result	88	88
Computer Software Problem	66	66
Unable to Obtain Readings	54	54
Problem with Software Installation	42	42
Connection Problem	38	38
Application Program Freezes, Becomes Nonfunctional	33	33
Break	33	33
Incomplete or Inadequate Connection	33	33
Device Sensing Problem	28	28
Battery Problem	25	25
Signal Artifact/Noise	23	23
Electrical /Electronic Property Problem	20	20
Unintended Application Program Shut Down	18	18
Output Problem	15	15
Failure to Sense	12	12
Application Program Problem	10	10
Communication or Transmission Problem	10	10
No Device Output	10	10
Sensing Intermittently	10	10
Display or Visual Feedback Problem	9	9
Loose or Intermittent Connection	7	7
Temperature Problem	7	7
Noise, Audible	7	7
Adverse Event Without Identified Device or Use Problem	7	7
Device Misassembled During Manufacturing /Shipping	6	6
Energy Output Problem	5	5
Intermittent Continuity	5	5
Unexpected Shutdown	5	5
Fitting Problem	5	5
Failure to Deliver Energy	5	5
Therapeutic or Diagnostic Output Failure	3	3
Intermittent Loss of Power	3	3
Failure to Deliver Shock/Stimulation	2	2
Overheating of Device	2	2
Failure of Device to Self-Test	2	2
No Apparent Adverse Event	2	2
Defibrillation/Stimulation Problem	2	2
Material Deformation	2	2
Device Fell	2	2
Wireless Communication Problem	2	2
Device Alarm System	2	2
Low Readings	1	1
Audible Prompt/Feedback Problem	1	1
Electrical Shorting	1	1
Material Twisted/Bent	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1565	1565
No Consequences Or Impact To Patient	48	48
Insufficient Information	36	36
Nerve Damage	21	21
Superficial (First Degree) Burn	13	13
No Known Impact Or Consequence To Patient	5	5
Burn(s)	5	5
Paralysis	4	4
Paresis	4	4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	3	3
Numbness	3	3
Unintended Extubation	3	3
Convulsion/Seizure	2	2
Loss of consciousness	2	2
Hemorrhage/Bleeding	2	2
Dysphasia	1	1
Electric Shock	1	1
Speech Disorder	1	1
Brain Injury	1	1
Fatigue	1	1
Diaphoresis	1	1
Dizziness	1	1
Muscle Weakness	1	1
Cramp(s) /Muscle Spasm(s)	1	1
Confusion/ Disorientation	1	1
Unspecified Nervous System Problem	1	1
No Patient Involvement	1	1
Twitching	1	1
Muscular Rigidity	1	1
Laceration(s)	1	1
Muscle/Tendon Damage	1	1
Unspecified Tissue Injury	1	1
Tachycardia	1	1
Stenosis	1	1
Ambulation Difficulties	1	1
Device Embedded In Tissue or Plaque	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Cadwell Industries Inc	II	Jul-12-2024
2	Cadwell Industries Inc	II	May-22-2024
3	Medtronic Xomed, Inc.	II	Apr-18-2025
4	Medtronic Xomed, Inc.	I	Jul-24-2024
5	Medtronic Xomed, Inc.	II	Jun-02-2022