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	2048	2049
No Display/Image	1946	1946
Display or Visual Feedback Problem	1227	1228
Output Problem	1188	1189
Computer Operating System Problem	897	897
Failure to Calibrate	661	661
Unexpected Shutdown	634	634
Computer Software Problem	586	592
Electrical /Electronic Property Problem	379	379
Failure to Power Up	340	340
Overheating of Device	336	336
Mechanical Problem	317	317
Communication or Transmission Problem	266	267
Use of Device Problem	262	262
Problem with Software Installation	250	250
Connection Problem	200	200
Material Integrity Problem	195	196
Power Problem	192	192
Application Program Freezes, Becomes Nonfunctional	186	192
Failure to Interrogate	183	184
Data Problem	167	170
Noise, Audible	150	150
Break	141	141
Inadequate User Interface	109	109
Operating System Becomes Nonfunctional	104	104
Battery Problem	88	88
Calibration Problem	84	84
Application Program Problem	78	79
Device Sensing Problem	72	72
Corroded	65	65
Interrogation Problem	64	64
Crack	57	57
Electrical Shorting	55	55
Loose or Intermittent Connection	55	55
Impedance Problem	53	53
Wireless Communication Problem	43	43
Signal Artifact/Noise	42	42
No Device Output	29	29
Incorrect, Inadequate or Imprecise Result or Readings	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
Erratic or Intermittent Display	14	14
Defective Device	13	13
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	6722	6739
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	8	8
Syncope/Fainting	5	5
No Code Available	5	5
Electric Shock	4	4
Loss of consciousness	4	4
Tachycardia	4	4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	3	3
Pocket Erosion	3	3
Arrhythmia	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
Headache	1	1
Heart Block	1	1
Convulsion/Seizure	1	1
Blurred Vision	1	1
Endocarditis	1	1
Anxiety	1	1
Sudden Cardiac Death	1	2
Bradycardia	1	1
Dyspnea	1	1
Pain	1	1
Chest Pain	1	1
Muscular Rigidity	1	1
Swelling	1	1
Ventricular Fibrillation	1	1
Burning Sensation	1	1
Abdominal Cramps	1	1
Dry Eye(s)	1	1
Presyncope	1	1
Ventricular Tachycardia	1	1
Infection, Indirect	1	1
Sepsis	1	1
Failure of Implant	1	1
Death	1	1
Convulsion, Clonic	1	1
Hearing Impairment	1	1

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