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	14

MDR Year	MDR Reports	MDR Events
2021	8538	8561
2022	7791	7805
2023	8463	8477
2024	6496	6503
2025	6060	6060
2026	1881	1882

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	10262	10273
Pacing Problem	4583	4585
Premature Discharge of Battery	4543	4545
Appropriate Term/Code Not Available	3050	3053
Over-Sensing	2409	2413
Failure to Interrogate	2206	2211
Mechanical Problem	1485	1485
Defective Device	1147	1148
Failure to Capture	868	871
Inappropriate or Unexpected Reset	822	822
False Alarm	749	752
Battery Problem	665	669
Inappropriate/Inadequate Shock/Stimulation	657	659
Pacemaker Found in Back-Up Mode	646	647
Signal Artifact/Noise	606	609
Reset Problem	564	565
Under-Sensing	533	534
Overheating of Device	523	523
Migration or Expulsion of Device	501	501
Electromagnetic Interference	499	500
Incorrect Measurement	468	469
Unable to Obtain Readings	465	465
Communication or Transmission Problem	452	453
Insufficient Information	442	442
No Pacing	389	391
Incorrect Interpretation of Signal	360	361
High impedance	323	324
Low impedance	309	318
Loose or Intermittent Connection	301	301
Device Sensing Problem	286	288
Premature Elective Replacement Indicator	250	253
Capturing Problem	232	232
Failure to Disconnect	205	207
Electrical /Electronic Property Problem	177	178
Output Problem	172	172
Data Problem	156	156
High Capture Threshold	148	149
Interrogation Problem	148	151
Impedance Problem	148	151
Misconnection	143	144
No Apparent Adverse Event	137	139
Use of Device Problem	131	131
Thermal Decomposition of Device	124	124
Failure to Deliver Shock/Stimulation	109	110
Break	109	110
Pacing Asynchronously	104	104
Difficult to Remove	103	103
Therapeutic or Diagnostic Output Failure	101	102
Failure to Charge	90	90
Device-Device Incompatibility	88	88

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	21298	21341
Unspecified Infection	6154	6161
Insufficient Information	2616	2619
Bradycardia	2039	2039
Syncope/Fainting	1059	1059
Arrhythmia	1036	1037
Discomfort	990	992
Dizziness	753	753
Pocket Erosion	736	737
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	621	621
Dyspnea	585	586
Bacterial Infection	567	567
Pain	552	552
Erythema	544	544
Erosion	515	515
Tachycardia	470	471
Swelling/ Edema	409	409
Chest Pain	399	399
Purulent Discharge	338	338
Fatigue	314	314
Sepsis	309	309
Wound Dehiscence	293	293
Fever	279	279
Endocarditis	275	275
Atrial Fibrillation	270	270
Hematoma	240	240
Heart Block	238	238
Cardiac Arrest	226	226
Non specific EKG/ECG Changes	223	223
Asystole	213	214
Fall	207	207
Heart Failure/Congestive Heart Failure	172	172
Drug Resistant Bacterial Infection	150	150
Muscle Weakness	145	145
Presyncope	126	126
Device Overstimulation of Tissue	108	108
No Consequences Or Impact To Patient	105	105
Low Blood Pressure/ Hypotension	102	102
Cardiomyopathy	96	96
Loss of consciousness	92	93
Foreign Body In Patient	81	81
Hypersensitivity/Allergic reaction	70	70
Ventricular Fibrillation	69	69
Failure of Implant	68	68
Fluid Discharge	67	67
Impaired Healing	65	65
Pericardial Effusion	62	62
Stroke/CVA	61	61
Twiddlers Syndrome	58	58
Nausea	56	56

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