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	180	180

Device Problems	MDRs with this Device Problem	Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings	637	637
Use of Device Problem	232	232
Inappropriate Audible Prompt/Feedback	140	140
False Negative Result	122	122
Failure to Power Up	107	107
False Positive Result	76	76
Computer Software Problem	54	54
Unable to Obtain Readings	38	38
Problem with Software Installation	34	34
Connection Problem	31	31
Break	26	26
Application Program Freezes, Becomes Nonfunctional	26	26
Battery Problem	22	22
Device Sensing Problem	21	21
Signal Artifact/Noise	20	20
Incomplete or Inadequate Connection	20	20
Output Problem	14	14
Failure to Sense	11	11
Sensing Intermittently	10	10
Communication or Transmission Problem	9	9
Unintended Application Program Shut Down	9	9
Application Program Problem	8	8
Display or Visual Feedback Problem	6	6
Adverse Event Without Identified Device or Use Problem	6	6
Device Misassembled During Manufacturing /Shipping	6	6
Noise, Audible	5	5
Temperature Problem	5	5
Loose or Intermittent Connection	5	5
Electrical /Electronic Property Problem	5	5
Intermittent Continuity	5	5
Energy Output Problem	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
No Device Output	3	3
Device Fell	2	2
Wireless Communication Problem	2	2
No Apparent Adverse Event	2	2
Failure of Device to Self-Test	2	2
Overheating of Device	2	2
Device Alarm System	2	2
Unexpected Shutdown	2	2
Material Fragmentation	1	1
Key or Button Unresponsive/not Working	1	1
Impedance Problem	1	1
Defective Component	1	1
Material Twisted/Bent	1	1
Audible Prompt/Feedback Problem	1	1
Material Deformation	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1255	1255
No Consequences Or Impact To Patient	48	48
Nerve Damage	16	16
Superficial (First Degree) Burn	13	13
No Known Impact Or Consequence To Patient	5	5
Burn(s)	5	5
Insufficient Information	4	4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	3	3
Numbness	3	3
Paresis	3	3
Unintended Extubation	3	3
Convulsion/Seizure	2	2
Hemorrhage/Bleeding	2	2
Loss of consciousness	2	2
Dysphasia	1	1
Electric Shock	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
Paralysis	1	1
Muscular Rigidity	1	1
Twitching	1	1
No Patient Involvement	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.	I	Jul-24-2024
4	Medtronic Xomed, Inc.	II	Jun-02-2022