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	55	56
2022	45	45
2023	150	150
2024	854	854
2025	948	948

Device Problems	MDRs with this Device Problem	Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings	1113	1113
Use of Device Problem	296	296
Inappropriate Audible Prompt/Feedback	212	212
False Negative Result	197	197
Failure to Power Up	118	118
False Positive Result	93	93
Computer Software Problem	80	80
Unable to Obtain Readings	57	57
Problem with Software Installation	48	48
Connection Problem	46	46
Incomplete or Inadequate Connection	46	46
Application Program Freezes, Becomes Nonfunctional	45	45
Break	40	40
Signal Artifact/Noise	35	35
Device Sensing Problem	31	31
Battery Problem	29	29
Electrical /Electronic Property Problem	25	25
Unintended Application Program Shut Down	18	18
Output Problem	16	16
Failure to Sense	14	14
Communication or Transmission Problem	13	13
No Device Output	11	11
Display or Visual Feedback Problem	10	10
Sensing Intermittently	10	10
Application Program Problem	10	10
Adverse Event Without Identified Device or Use Problem	9	9
Device Misassembled During Manufacturing /Shipping	8	8
Loose or Intermittent Connection	8	8
Temperature Problem	8	8
Unexpected Shutdown	7	7
Noise, Audible	7	7
Fitting Problem	6	6
Intermittent Continuity	6	6
Energy Output Problem	5	5
Intermittent Loss of Power	5	5
Failure to Deliver Energy	5	5
Device Fell	4	4
Activation Problem	4	4
Therapeutic or Diagnostic Output Failure	3	3
Wireless Communication Problem	3	3
Insufficient Information	3	3
No Apparent Adverse Event	3	3
Crack	2	2
Device Alarm System	2	3
Audible Prompt/Feedback Problem	2	2
Material Deformation	2	2
Defibrillation/Stimulation Problem	2	2
Mechanical Problem	2	2
Failure to Deliver Shock/Stimulation	2	2
Overheating of Device	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1938	1938
Insufficient Information	90	91
No Consequences Or Impact To Patient	48	48
Nerve Damage	23	23
Superficial (First Degree) Burn	13	13
Paralysis	6	6
No Known Impact Or Consequence To Patient	5	5
Burn(s)	5	5
Paresis	4	4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	3	3
Numbness	3	3
Convulsion/Seizure	3	3
Loss of consciousness	3	3
Unintended Extubation	3	3
Convulsion, Tonic	2	2
Hemorrhage/Bleeding	2	2
Dysphasia	1	1
Electric Shock	1	1
Speech Disorder	1	1
Convulsion, Clonic	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
Vaso-Vagal Response	1	1
Foreign Body In Patient	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