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	1
INOMED MEDIZINTECHNIK GMBH
	SUBSTANTIALLY EQUIVALENT	1
MEDTRONIC XOMED, INC.
	SUBSTANTIALLY EQUIVALENT	1
NEUROSOFT LTD
	SUBSTANTIALLY EQUIVALENT	1
SAFEOP SURGICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
SOTERIX MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1

MDR Year	MDR Reports	MDR Events
2018	58	58
2019	94	94
2020	65	65
2021	54	54
2022	46	46
2023	12	12

Device Problems	MDRs with this Device Problem	Events in those MDRs
Use of Device Problem	193	193
Mechanical Problem	18	18
Device Sensing Problem	18	18
Connection Problem	17	17
Break	16	16
Unable to Obtain Readings	11	11
Failure to Sense	11	11
Application Program Problem	10	10
Adverse Event Without Identified Device or Use Problem	9	9
Output Problem	8	8
Unintended Application Program Shut Down	8	8
Appropriate Term/Code Not Available	7	7
Insufficient Information	6	6
Failure to Deliver Energy	6	6
Display or Visual Feedback Problem	5	5
Electrical /Electronic Property Problem	5	5
Device Operates Differently Than Expected	5	5
Sensing Intermittently	5	5
Communication or Transmission Problem	4	4
Detachment of Device or Device Component	4	4
Unexpected Shutdown	4	4
Intermittent Continuity	4	4
False Positive Result	4	4
Computer Software Problem	3	3
Incorrect, Inadequate or Imprecise Result or Readings	3	3
Energy Output Problem	3	3
Device Stops Intermittently	3	3
Noise, Audible	3	3
Therapeutic or Diagnostic Output Failure	3	3
No Apparent Adverse Event	3	3
Impedance Problem	3	3
Temperature Problem	2	2
Failure to Calibrate	2	2
Audible Prompt/Feedback Problem	2	2
Incomplete or Inadequate Connection	2	2
Fitting Problem	2	2
Defective Component	2	2
Overheating of Device	2	2
False Negative Result	2	2
Circuit Failure	2	2
Device Alarm System	1	1
Signal Artifact/Noise	1	1
No Display/Image	1	1
Entrapment of Device	1	1
Material Fragmentation	1	1
Image Display Error/Artifact	1	1
Loose or Intermittent Connection	1	1
Loss of Power	1	1
Device Emits Odor	1	1
Failure to Analyze Signal	1	1
Failure to Read Input Signal	1	1
Smoking	1	1
Solder Joint Fracture	1	1
Device Issue	1	1
Intermittent Shock/Stimulation	1	1
Device Inoperable	1	1
Improper or Incorrect Procedure or Method	1	1
Intermittent Program or Algorithm Execution	1	1
Application Program Freezes, Becomes Nonfunctional	1	1
Wireless Communication Problem	1	1
Complete Loss of Power	1	1
Data Problem	1	1
Low Readings	1	1
Battery Problem	1	1
Calibration Problem	1	1
Power Problem	1	1
Inadequate User Interface	1	1
Material Deformation	1	1
Failure of Device to Self-Test	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Consequences Or Impact To Patient	154	154
No Clinical Signs, Symptoms or Conditions	130	130
No Known Impact Or Consequence To Patient	41	41
No Patient Involvement	9	9
No Information	5	5
Not Applicable	3	3
Nerve Damage	3	3
Insufficient Information	2	2
No Code Available	1	1
Cramp(s) /Muscle Spasm(s)	1	1
Muscle/Tendon Damage	1	1
Unspecified Tissue Injury	1	1
Unintended Extubation	1	1
Neurological Deficit/Dysfunction	1	1
Pain	1	1
Paralysis	1	1
Tachycardia	1	1
Tissue Damage	1	1
Twitching	1	1
Burn(s)	1	1
Death	1	1
Emotional Changes	1	1
Hearing Loss	1	1
Hemorrhage/Bleeding	1	1
Muscle Weakness	1	1
Lead(s), Burn(s) From	1	1
Radiation Exposure, Unintended	1	1
Device Embedded In Tissue or Plaque	1	1
Brain Injury	1	1
Depression	1	1
Paraplegia	1	1
Low Oxygen Saturation	1	1
Ambulation Difficulties	1	1
Bronchospasm	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Medtronic Xomed, Inc.	II	Jun-02-2022