TPLC - Total Product Life Cycle

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Device Problems	MDRs with this Device Problem	Events in those MDRs
Device Difficult to Program or Calibrate	1773	1774
No Display/Image	1725	1725
Display or Visual Feedback Problem	1176	1177
Output Problem	1130	1131
Computer Operating System Problem	748	748
Unexpected Shutdown	525	525
Failure to Calibrate	506	506
Computer Software Problem	498	504
Failure to Power Up	307	307
Electrical /Electronic Property Problem	307	307
Overheating of Device	286	286
Mechanical Problem	277	277
Communication or Transmission Problem	227	228
Problem with Software Installation	218	218
Use of Device Problem	212	212
Power Problem	180	180
Material Integrity Problem	177	178
Application Program Freezes, Becomes Nonfunctional	175	181
Connection Problem	161	161
Failure to Interrogate	158	159
Data Problem	136	139
Noise, Audible	132	132
Break	119	119
Battery Problem	79	79
Application Program Problem	77	78
Operating System Becomes Nonfunctional	77	77
Inadequate User Interface	67	67
Calibration Problem	66	66
Corroded	62	62
Device Sensing Problem	62	62
Interrogation Problem	53	53
Impedance Problem	48	48
Loose or Intermittent Connection	48	48
Electrical Shorting	46	46
Crack	45	45
Wireless Communication Problem	41	41
Signal Artifact/Noise	31	31
Incorrect, Inadequate or Imprecise Result or Readings	28	28
No Device Output	26	26
Insufficient Information	25	25
Device Emits Odor	20	20
Component Missing	20	20
Contamination	15	15
Failure to Shut Off	15	15
Erratic or Intermittent Display	12	12
Moisture Damage	12	12
Adverse Event Without Identified Device or Use Problem	12	13
Defective Device	11	11
Over-Sensing	10	10
Patient Data Problem	10	10

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	6719	6736
No Patient Involvement	698	698
No Consequences Or Impact To Patient	476	476
No Known Impact Or Consequence To Patient	237	237
Insufficient Information	57	58
No Information	39	39
Asystole	10	10
Dizziness	8	8
Cardiac Arrest	7	7
Shock	7	7
Unspecified Infection	6	7
Syncope/Fainting	5	5
No Code Available	5	5
Electric Shock	4	4
Tachycardia	4	4
Loss of consciousness	4	4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	3	3
Arrhythmia	3	3
Shock from Patient Lead(s)	3	3
Injury	3	3
Bacterial Infection	3	3
Discomfort	2	2
Hearing Impairment	1	1
Ventricular Tachycardia	1	1
Presyncope	1	1
Dry Eye(s)	1	1
Abdominal Cramps	1	1
Ventricular Fibrillation	1	1
Burning Sensation	1	1
Chest Pain	1	1
Muscular Rigidity	1	1
Dyspnea	1	1
Pain	1	1
Bradycardia	1	1
Anxiety	1	1
Blurred Vision	1	1
Convulsion/Seizure	1	1
Headache	1	1
Heart Block	1	1
Low Blood Pressure/ Hypotension	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Medtronic, Inc.	II	Jul-17-2025