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	2050	2051
No Display/Image	1957	1957
Display or Visual Feedback Problem	1258	1259
Output Problem	1191	1192
Computer Operating System Problem	899	899
Failure to Calibrate	661	661
Unexpected Shutdown	639	639
Computer Software Problem	591	597
Electrical /Electronic Property Problem	382	382
Failure to Power Up	344	344
Overheating of Device	337	337
Mechanical Problem	317	317
Communication or Transmission Problem	271	272
Use of Device Problem	264	264
Problem with Software Installation	250	250
Connection Problem	201	201
Material Integrity Problem	199	200
Power Problem	192	192
Application Program Freezes, Becomes Nonfunctional	188	194
Failure to Interrogate	184	185
Data Problem	167	170
Noise, Audible	151	151
Break	142	142
Inadequate User Interface	112	112
Operating System Becomes Nonfunctional	105	105
Battery Problem	88	88
Calibration Problem	84	84
Application Program Problem	82	83
Device Sensing Problem	73	73
Corroded	65	65
Interrogation Problem	64	64
Electrical Shorting	57	57
Crack	57	57
Loose or Intermittent Connection	56	56
Impedance Problem	53	53
Wireless Communication Problem	44	44
Signal Artifact/Noise	42	42
Incorrect, Inadequate or Imprecise Result or Readings	30	30
No Device Output	29	29
Insufficient Information	27	27
Device Emits Odor	25	25
Incorrect Measurement	25	25
Component Missing	23	23
Adverse Event Without Identified Device or Use Problem	21	22
Contamination	20	20
Failure to Shut Off	18	18
Defective Device	14	14
Erratic or Intermittent Display	14	14
Failure to Sense	12	12
Moisture Damage	12	12

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	6795	6812
No Patient Involvement	1258	1258
No Known Impact Or Consequence To Patient	803	803
No Consequences Or Impact To Patient	485	485
No Information	65	65
Insufficient Information	58	59
Unspecified Infection	12	13
Dizziness	10	10
Asystole	10	10
Cardiac Arrest	9	9
Shock	9	9
Syncope/Fainting	5	5
No Code Available	5	5
Tachycardia	5	5
Electric Shock	4	4
Loss of consciousness	4	4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	3	3
Arrhythmia	3	3
Pocket Erosion	3	3
Shock from Patient Lead(s)	3	3
Bacterial Infection	3	3
Injury	3	3
Discomfort	2	2
Low Blood Pressure/ Hypotension	1	1
Heart Block	1	1
Headache	1	1
Convulsion/Seizure	1	1
Blurred Vision	1	1
Endocarditis	1	1
Anxiety	1	1
Sudden Cardiac Death	1	2
Bradycardia	1	1
Pain	1	1
Dyspnea	1	1
Swelling	1	1
Muscular Rigidity	1	1
Chest Pain	1	1
Burning Sensation	1	1
Ventricular Fibrillation	1	1
Abdominal Cramps	1	1
Dry Eye(s)	1	1
Presyncope	1	1
Infection, Indirect	1	1
Ventricular Tachycardia	1	1
Sepsis	1	1
Failure of Implant	1	1
Convulsion, Clonic	1	1
Death	1	1
Hearing Impairment	1	1

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