TPLC - Total Product Life Cycle

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Device Problems	MDRs with this Device Problem	Events in those MDRs
No Display/Image	1548	1548
Device Difficult to Program or Calibrate	1428	1429
Display or Visual Feedback Problem	1351	1352
Output Problem	682	683
Computer Operating System Problem	602	602
Computer Software Problem	467	473
Unexpected Shutdown	435	435
Failure to Calibrate	361	361
Electrical /Electronic Property Problem	282	282
Failure to Power Up	262	262
Overheating of Device	246	246
Mechanical Problem	235	235
Application Program Freezes, Becomes Nonfunctional	228	234
Communication or Transmission Problem	194	195
Problem with Software Installation	168	168
Use of Device Problem	163	163
Power Problem	160	160
Material Integrity Problem	152	153
Failure to Interrogate	144	145
Connection Problem	136	136
Noise, Audible	120	120
Data Problem	117	120
Break	102	102
Application Program Problem	82	83
Operating System Becomes Nonfunctional	79	79
Battery Problem	69	69
Corroded	54	54
Inadequate User Interface	51	51
Device Sensing Problem	50	50
Calibration Problem	50	50
Electrical Shorting	47	47
Impedance Problem	47	47
Wireless Communication Problem	41	41
Loose or Intermittent Connection	39	39
Crack	34	34
Interrogation Problem	31	31
Incorrect, Inadequate or Imprecise Result or Readings	26	26
No Device Output	25	25
Signal Artifact/Noise	21	21
Component Missing	20	20
Device Emits Odor	15	15
Failure to Shut Off	14	14
Date/Time-Related Software Problem	13	13
Erratic or Intermittent Display	11	11
Contamination	11	11
Adverse Event Without Identified Device or Use Problem	10	11
Moisture Damage	10	10
Intermittent Communication Failure	9	9
Patient Data Problem	9	9
Defective Device	9	9

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	6806	6823
Insufficient Information	57	58
Asystole	10	10
Shock	8	8
Dizziness	6	6
No Known Impact Or Consequence To Patient	6	6
Unspecified Infection	5	6
Syncope/Fainting	5	5
No Patient Involvement	5	5
Tachycardia	5	5
Loss of consciousness	4	4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	3	3
Electric Shock	3	3
Shock from Patient Lead(s)	3	3
Cardiac Arrest	3	3
Arrhythmia	2	2
No Code Available	2	2
No Information	2	2
Discomfort	2	2
Pain	2	2
Bacterial Infection	2	2
No Consequences Or Impact To Patient	2	2
Hearing Impairment	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
Dyspnea	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