TPLC - Total Product Life Cycle

• Device: stimulator, electrical, evoked response
• 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
NEUROSOFT LTD
	SUBSTANTIALLY EQUIVALENT	1
QUANTALX NEUROSCIENCE
	SUBSTANTIALLY EQUIVALENT	1
SAFEOP SURGICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
SOTERIX MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	2

MDR Year	MDR Reports	MDR Events
2019	94	94
2020	65	65
2021	54	54
2022	45	45
2023	150	150
2024	771	771

Device Problems	MDRs with this Device Problem	Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings	489	489
Use of Device Problem	267	267
Inappropriate Audible Prompt/Feedback	106	106
Failure to Power Up	101	101
False Negative Result	92	92
False Positive Result	61	61
Computer Software Problem	50	50
Problem with Software Installation	30	30
Unable to Obtain Readings	28	28
Connection Problem	25	25
Break	25	25
Device Sensing Problem	24	24
Application Program Freezes, Becomes Nonfunctional	19	19
Output Problem	16	16
Signal Artifact/Noise	15	15
Failure to Sense	12	12
Battery Problem	12	12
Incomplete or Inadequate Connection	11	11
Failure to Deliver Energy	10	10
Sensing Intermittently	10	10
Adverse Event Without Identified Device or Use Problem	10	10
Application Program Problem	9	9
Unintended Application Program Shut Down	9	9
Mechanical Problem	8	8
Communication or Transmission Problem	8	8
Display or Visual Feedback Problem	7	7
Insufficient Information	7	7
Intermittent Continuity	6	6
Electrical /Electronic Property Problem	6	6
Device Misassembled During Manufacturing /Shipping	6	6
Energy Output Problem	6	6
Noise, Audible	6	6
Loose or Intermittent Connection	5	5
Detachment of Device or Device Component	4	4
Fitting Problem	4	4
Temperature Problem	4	4
Therapeutic or Diagnostic Output Failure	3	3
Overheating of Device	3	3
Intermittent Loss of Power	3	3
No Apparent Adverse Event	3	3
Defective Component	2	2
Device Fell	2	2
Wireless Communication Problem	2	2
Device Alarm System	2	2
Power Problem	2	2
Loss of Power	1	1
Failure to Deliver Shock/Stimulation	1	1
Improper or Incorrect Procedure or Method	1	1
Intermittent Shock/Stimulation	1	1
Loss of Data	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1015	1015
No Consequences Or Impact To Patient	120	120
No Known Impact Or Consequence To Patient	21	21
Nerve Damage	15	15
No Information	5	5
No Patient Involvement	4	4
Unintended Extubation	3	3
Hemorrhage/Bleeding	3	3
Paresis	3	3
Insufficient Information	3	3
Numbness	3	3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	3	3
Paralysis	2	2
Tachycardia	2	2
Convulsion/Seizure	2	2
Loss of consciousness	2	2
No Code Available	1	1
Dizziness	1	1
Muscle Weakness	1	1
Cramp(s) /Muscle Spasm(s)	1	1
Not Applicable	1	1
Neurological Deficit/Dysfunction	1	1
Confusion/ Disorientation	1	1
Burn(s)	1	1
Diaphoresis	1	1
Brain Injury	1	1
Fatigue	1	1
Speech Disorder	1	1
Muscular Rigidity	1	1
Twitching	1	1
Electric Shock	1	1
Laceration(s)	1	1
Pain	1	1
Muscle/Tendon Damage	1	1
Stenosis	1	1
Bronchospasm	1	1
Unspecified Tissue Injury	1	1
Tissue Damage	1	1
Death	1	1
Dysphasia	1	1
Low Oxygen Saturation	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