TPLC - Total Product Life Cycle

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Device	stimulator, electrical, evoked response
Product Code	GWF
Regulation Number	882.1870
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings	269	269
Use of Device Problem	246	246
Failure to Power Up	82	82
Inappropriate Audible Prompt/Feedback	62	62
False Negative Result	46	46
False Positive Result	40	40
Computer Software Problem	36	36
Break	23	23
Device Sensing Problem	22	22
Unable to Obtain Readings	22	22
Connection Problem	21	21
Output Problem	15	15
Signal Artifact/Noise	14	14
Problem with Software Installation	14	14
Failure to Deliver Energy	10	10
Application Program Freezes, Becomes Nonfunctional	10	10
Application Program Problem	9	9
Adverse Event Without Identified Device or Use Problem	9	9
Failure to Sense	9	9
Unintended Application Program Shut Down	9	9
Mechanical Problem	8	8
Communication or Transmission Problem	8	8
Insufficient Information	7	7
Noise, Audible	6	6
Display or Visual Feedback Problem	6	6
Intermittent Continuity	6	6
Battery Problem	6	6
Energy Output Problem	6	6
Device Misassembled During Manufacturing /Shipping	5	5
Incomplete or Inadequate Connection	5	5
Electrical /Electronic Property Problem	5	5
Detachment of Device or Device Component	4	4
Therapeutic or Diagnostic Output Failure	3	3
No Apparent Adverse Event	3	3
Sensing Intermittently	3	3
Overheating of Device	3	3
Loose or Intermittent Connection	3	3
Temperature Problem	3	3
Defective Component	2	2
Wireless Communication Problem	2	2
Power Problem	2	2
Fitting Problem	2	2
Smoking	1	1
Key or Button Unresponsive/not Working	1	1
Device Fell	1	1
Material Fragmentation	1	1
Impedance Problem	1	1
Image Display Error/Artifact	1	1
Crack	1	1
Audible Prompt/Feedback Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	670	670
No Consequences Or Impact To Patient	120	120
No Known Impact Or Consequence To Patient	21	21
Nerve Damage	12	12
No Information	5	5
No Patient Involvement	4	4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	3	3
Hemorrhage/Bleeding	3	3
Insufficient Information	3	3
Unintended Extubation	2	2
Loss of consciousness	2	2
Convulsion/Seizure	2	2
Tachycardia	2	2
Paralysis	2	2
Numbness	2	2
Device Embedded In Tissue or Plaque	1	1
Ambulation Difficulties	1	1
Low Oxygen Saturation	1	1
Tissue Damage	1	1
Unspecified Tissue Injury	1	1
Bronchospasm	1	1
Stenosis	1	1
Muscle/Tendon Damage	1	1
Paresis	1	1
Pain	1	1
Laceration(s)	1	1
Twitching	1	1
Muscular Rigidity	1	1
Burn(s)	1	1
Confusion/ Disorientation	1	1
Neurological Deficit/Dysfunction	1	1
Cramp(s) /Muscle Spasm(s)	1	1
Muscle Weakness	1	1
Dizziness	1	1
No Code Available	1	1
Not Applicable	1	1
Diaphoresis	1	1
Brain Injury	1	1
Fatigue	1	1
Death	1	1
Dysphasia	1	1