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	572	572

Device Problems	MDRs with this Device Problem	Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings	1575	1575
Inappropriate Audible Prompt/Feedback	286	286
Use of Device Problem	280	280
False Negative Result	258	258
Failure to Power Up	131	131
Computer Software Problem	103	103
False Positive Result	98	98
Connection Problem	69	69
Unable to Obtain Readings	69	69
Application Program Freezes or Fails to Launch	62	62
Incomplete or Inadequate Connection	59	59
Problem with Software Installation	54	54
Break	46	46
Signal Artifact/Noise	42	42
Battery Problem	42	42
Device Sensing Problem	32	32
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
Fitting Problem	6	6
Intermittent Continuity	6	6
Wireless Communication Problem	5	5
Device Fell	5	5
Intermittent Loss of Power	5	5
Energy Output Problem	4	4
Activation Problem	4	4
Failure to Deliver Energy	4	4
Audible Prompt/Feedback Problem	3	3
Device Provides Uninformative Message	3	3
Material Deformation	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
Crack	2	2
Malposition of Device	2	2
Component Missing	2	2
Insufficient Device Problem Information	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	2524	2524
Insufficient Information	169	170
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
Hemorrhage/Blood Loss/Bleeding	3	3
Convulsion/Seizure	3	3
Loss of consciousness	3	3
Unintended Extubation	3	3
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	3	3
Convulsion, Tonic	2	2
Twitching	2	2
Muscle Weakness/Atrophy	1	1
Dysphasia	1	1
Convulsion, Clonic	1	1
Speech Disorder	1	1
Fatigue	1	1
Brain Injury	1	1
Diaphoresis	1	1
Dizziness	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
Ambulation or Postural Difficulties	1	1
Laceration(s)	1	1
Muscle/Tendon Damage	1	1
Limb Pain	1	1
Tachycardia	1	1
Stenosis	1	1
Unspecified Tissue Injury	1	1
Device Embedded In Tissue or Plaque	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Alphatec Spine, Inc.	II	Jul-23-2026
2	Cadwell Industries Inc	II	Jul-12-2024
3	Cadwell Industries Inc	II	May-22-2024
4	Medtronic Xomed, Inc.	II	Apr-18-2025
5	Medtronic Xomed, Inc.	I	Jul-24-2024
6	Medtronic Xomed, Inc.	II	Jun-02-2022