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	3
CADWELL INDUSTRIES, INC.
	SUBSTANTIALLY EQUIVALENT	1
INOMED MEDIZINTECHNIK GMBH
	SUBSTANTIALLY EQUIVALENT	2
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
2021	55	56
2022	45	45
2023	150	150
2024	854	854
2025	1042	1042
2026	390	390

Device Problems	MDRs with this Device Problem	Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings	1441	1441
Use of Device Problem	269	269
Inappropriate Audible Prompt/Feedback	263	263
False Negative Result	242	242
Failure to Power Up	127	127
False Positive Result	98	98
Computer Software Problem	97	97
Unable to Obtain Readings	68	68
Connection Problem	65	65
Incomplete or Inadequate Connection	58	58
Application Program Freezes, Becomes Nonfunctional	58	58
Problem with Software Installation	53	53
Break	44	44
Signal Artifact/Noise	40	40
Battery Problem	38	38
Device Sensing Problem	30	30
Electrical /Electronic Property Problem	25	25
Unintended Application Program Shut Down	18	18
Output Problem	15	15
Failure to Sense	13	13
Communication or Transmission Problem	12	12
No Device Output	11	11
Application Program Problem	11	11
Device Misassembled During Manufacturing /Shipping	10	10
Temperature Problem	9	9
Sensing Intermittently	9	9
Display or Visual Feedback Problem	9	9
Adverse Event Without Identified Device or Use Problem	9	9
Noise, Audible	8	8
Loose or Intermittent Connection	8	8
Unexpected Shutdown	7	7
Fitting Problem	6	6
Intermittent Continuity	6	6
Device Fell	5	5
Wireless Communication Problem	5	5
Intermittent Loss of Power	5	5
Failure to Deliver Energy	4	4
Energy Output Problem	4	4
Activation Problem	4	4
Therapeutic or Diagnostic Output Failure	3	3
Insufficient Information	3	3
Audible Prompt/Feedback Problem	3	3
Electrical Shorting	3	3
No Apparent Adverse Event	3	3
Failure of Device to Self-Test	3	3
Failure to Deliver Shock/Stimulation	3	3
Component Missing	2	2
Defibrillation/Stimulation Problem	2	2
Crack	2	2
Mechanical Problem	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	2357	2357
Insufficient Information	143	144
Nerve Damage	25	25
Superficial (First Degree) Burn	13	13
Paralysis	6	6
Burn(s)	5	5
Electric Shock	4	4
Paresis	4	4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	3	3
Numbness	3	3
Convulsion/Seizure	3	3
Hemorrhage/Bleeding	3	3
Loss of consciousness	3	3
Unintended Extubation	3	3
Convulsion, Tonic	2	2
Dysphasia	1	1
Convulsion, Clonic	1	1
Speech Disorder	1	1
Fatigue	1	1
Brain Injury	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
Vaso-Vagal Response	1	1
Foreign Body In Patient	1	1
Muscular Rigidity	1	1
Twitching	1	1
Laceration(s)	1	1
Muscle/Tendon Damage	1	1
Tachycardia	1	1
Stenosis	1	1
Unspecified Tissue Injury	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