TPLC - Total Product Life Cycle

• Device: pulse generator, permanent, implantable
• Definition: Intended as a permanent implant to deliver pacing pulses and other pacing therapies through pacing leads implanted in the heart.
• Product Code: NVZ
• Device Class: 3

Premarket Approvals (PMA)
2021	2022	2023	2024	2025	2026
40	44	39	42	39	9

MDR Year	MDR Reports	MDR Events
2021	8538	8561
2022	7791	7805
2023	8463	8477
2024	6496	6503
2025	6059	6059
2026	1348	1348

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	10086	10097
Pacing Problem	4495	4497
Premature Discharge of Battery	4486	4488
Appropriate Term/Code Not Available	3007	3010
Over-Sensing	2392	2396
Failure to Interrogate	2185	2190
Mechanical Problem	1462	1462
Defective Device	1147	1148
Failure to Capture	860	863
Inappropriate or Unexpected Reset	805	805
False Alarm	725	728
Battery Problem	655	659
Inappropriate/Inadequate Shock/Stimulation	654	656
Pacemaker Found in Back-Up Mode	646	647
Signal Artifact/Noise	600	603
Reset Problem	555	556
Under-Sensing	527	528
Overheating of Device	521	521
Migration or Expulsion of Device	493	493
Electromagnetic Interference	484	485
Incorrect Measurement	465	466
Unable to Obtain Readings	462	462
Communication or Transmission Problem	447	448
Insufficient Information	439	439
No Pacing	384	386
Incorrect Interpretation of Signal	357	358
High impedance	322	323
Low impedance	308	317
Loose or Intermittent Connection	298	298
Device Sensing Problem	282	284
Premature Elective Replacement Indicator	242	245
Capturing Problem	228	228
Failure to Disconnect	200	202
Electrical /Electronic Property Problem	174	175
Output Problem	172	172
Data Problem	156	156
High Capture Threshold	147	148
Impedance Problem	146	149
Interrogation Problem	146	149
Misconnection	140	141
Use of Device Problem	130	130
No Apparent Adverse Event	127	128
Thermal Decomposition of Device	123	123
Failure to Deliver Shock/Stimulation	109	110
Break	107	108
Pacing Asynchronously	101	101
Difficult to Remove	101	101
Therapeutic or Diagnostic Output Failure	101	102
Failure to Charge	89	89
Device-Device Incompatibility	88	88

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	21046	21089
Unspecified Infection	6059	6066
Insufficient Information	2588	2590
Bradycardia	2002	2002
Syncope/Fainting	1046	1046
Arrhythmia	1024	1025
Discomfort	971	973
Dizziness	741	741
Pocket Erosion	728	729
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	613	613
Dyspnea	572	573
Bacterial Infection	552	552
Pain	540	540
Erythema	526	526
Erosion	496	496
Tachycardia	463	464
Swelling/ Edema	399	399
Chest Pain	394	394
Purulent Discharge	326	326
Fatigue	309	309
Sepsis	304	304
Wound Dehiscence	284	284
Fever	272	272
Endocarditis	268	268
Atrial Fibrillation	265	265
Hematoma	237	237
Heart Block	232	232
Cardiac Arrest	226	226
Non specific EKG/ECG Changes	218	218
Asystole	209	210
Fall	203	203
Heart Failure/Congestive Heart Failure	167	167
Drug Resistant Bacterial Infection	142	142
Muscle Weakness	142	142
Presyncope	125	125
Device Overstimulation of Tissue	108	108
No Consequences Or Impact To Patient	105	105
Low Blood Pressure/ Hypotension	101	101
Cardiomyopathy	94	94
Loss of consciousness	92	93
Foreign Body In Patient	81	81
Hypersensitivity/Allergic reaction	69	69
Ventricular Fibrillation	69	69
Failure of Implant	68	68
Fluid Discharge	65	65
Impaired Healing	65	65
Pericardial Effusion	62	62
Stroke/CVA	60	60
Twiddlers Syndrome	58	58
Thrombosis/Thrombus	55	55

Recalls
Manufacturer		Recall Class	Date Posted
1	Abbott Medical	III	Nov-26-2024
2	Medtronic Inc.	II	Sep-13-2024
3	Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)	II	Dec-16-2021
4	Medtronic, Inc.	II	Jul-23-2025
5	Medtronic, Inc.	II	Jun-06-2025
6	St. Jude Medical, Cardian Rhythm Management Division	I	May-07-2021