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
TIME IS BRAIN, S.L.
	SUBSTANTIALLY EQUIVALENT	1

MDR Year	MDR Reports	MDR Events
2021	55	56
2022	45	45
2023	150	150
2024	854	854
2025	1042	1042
2026	473	473

Device Problems	MDRs with this Device Problem	Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings	1505	1505
Use of Device Problem	274	274
Inappropriate Audible Prompt/Feedback	271	271
False Negative Result	249	249
Failure to Power Up	128	128
Computer Software Problem	100	100
False Positive Result	98	98
Unable to Obtain Readings	69	69
Connection Problem	66	66
Application Program Freezes or Fails to Launch	59	59
Incomplete or Inadequate Connection	59	59
Problem with Software Installation	54	54
Break	46	46
Battery Problem	42	42
Signal Artifact/Noise	42	42
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	14	14
Communication or Transmission Problem	12	12
Device Misassembled During Manufacturing /Shipping	12	12
Application Program Problem	11	11
No Device Output	11	11
Temperature Problem	10	10
Display or Visual Feedback Problem	10	10
Sensing Intermittently	9	9
Loose or Intermittent Connection	9	9
Noise, Audible	8	8
Adverse Event Without Identified Device or Use Problem	7	7
Unexpected Shutdown	7	7
Intermittent Continuity	6	6
Fitting Problem	6	6
Wireless Communication Problem	5	5
Device Fell	5	5
Intermittent Loss of Power	5	5
Failure to Deliver Energy	4	4
Energy Output Problem	4	4
Activation Problem	4	4
No Apparent Adverse Event	3	3
Failure of Device to Self-Test	3	3
Electrical Shorting	3	3
Audible Prompt/Feedback Problem	3	3
Failure to Deliver Shock/Stimulation	3	3
Device Provides Uninformative Message	3	3
Malposition of Device	2	2
Component Missing	2	2
Material Deformation	2	2
Crack	2	2
Defibrillation/Stimulation Problem	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	2432	2432
Insufficient Information	157	158
Nerve Damage	25	25
Superficial (First Degree) Burn	13	13
Facial Paralysis	7	7
Paralysis	6	6
Burn(s)	5	5
Electric Shock	4	4
Paresis	4	4
Numbness	3	3
Unintended Extubation	3	3
Loss of consciousness	3	3
Convulsion/Seizure	3	3
Hemorrhage/Blood Loss/Bleeding	3	3
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	3	3
Twitching	2	2
Convulsion, Tonic	2	2
Dizziness	1	1
Limb Pain	1	1
Convulsion, Clonic	1	1
Brain Injury	1	1
Ambulation or Postural Difficulties	1	1
Cramp(s) /Muscle Spasm(s)	1	1
Diaphoresis	1	1
Vaso-Vagal Response	1	1
Device Embedded In Tissue or Plaque	1	1
Laceration(s)	1	1
Unspecified Nervous System Problem	1	1
Confusion/ Disorientation	1	1
Speech Disorder	1	1
Muscle/Tendon Damage	1	1
Foreign Body In Patient	1	1
Tachycardia	1	1
Unspecified Tissue Injury	1	1
Fatigue	1	1
Muscular Rigidity	1	1
Dysphasia	1	1
Muscle Weakness/Atrophy	1	1
Stenosis	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