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)
2020	2021	2022	2023	2024	2025
73	40	44	39	42	15

MDR Year	MDR Reports	MDR Events
2020	8337	8337
2021	8537	8537
2022	7791	7791
2023	8467	8467
2024	6502	6502
2025	2505	2505

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	10331	10331
Premature Discharge of Battery	4719	4719
Pacing Problem	4599	4599
Appropriate Term/Code Not Available	3104	3104
Over-Sensing	2882	2882
Failure to Interrogate	2398	2398
Mechanical Problem	1435	1435
Battery Problem	1181	1181
Defective Device	1131	1131
Inappropriate or Unexpected Reset	999	999
Failure to Capture	944	944
Pacemaker Found in Back-Up Mode	886	886
Unable to Obtain Readings	855	855
Inappropriate/Inadequate Shock/Stimulation	803	803
Signal Artifact/Noise	715	715
False Alarm	700	700
Incorrect Measurement	694	694
Overheating of Device	648	648
Under-Sensing	638	638
Reset Problem	594	594
Communication or Transmission Problem	527	527
Migration or Expulsion of Device	484	484
Electromagnetic Interference	444	444
Incorrect Interpretation of Signal	437	437
Insufficient Information	432	432
No Pacing	426	426
Device Sensing Problem	393	393
High impedance	355	355
Low impedance	330	330
Loose or Intermittent Connection	290	290
Premature Elective Replacement Indicator	276	276
Capturing Problem	258	258
Data Problem	241	241
Output Problem	236	236
Electrical /Electronic Property Problem	200	200
High Capture Threshold	186	186
Failure to Disconnect	182	182
Impedance Problem	163	163
Misconnection	160	160
Interrogation Problem	156	156
Use of Device Problem	148	148
Failure to Deliver Shock/Stimulation	147	147
Thermal Decomposition of Device	130	130
Failure to Charge	129	129
Break	115	115
Missing Test Results	108	108
Therapeutic or Diagnostic Output Failure	101	101
Pacing Asynchronously	100	100
Intermittent Capture	100	100
Incorrect, Inadequate or Imprecise Result or Readings	95	95

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	19269	19269
Unspecified Infection	6475	6475
No Known Impact Or Consequence To Patient	2727	2727
Insufficient Information	2338	2338
No Consequences Or Impact To Patient	2085	2085
Bradycardia	1998	1998
Arrhythmia	1025	1025
Syncope/Fainting	982	982
Discomfort	922	922
Dizziness	824	824
Pocket Erosion	773	773
Dyspnea	589	589
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	568	568
Pain	545	545
Bacterial Infection	487	487
Tachycardia	438	438
Chest Pain	421	421
Erosion	419	419
Erythema	383	383
Fatigue	321	321
Sepsis	306	306
Swelling/ Edema	305	305
Atrial Fibrillation	269	269
Endocarditis	266	266
Cardiac Arrest	265	265
Hematoma	244	244
Fever	240	240
Wound Dehiscence	231	231
Non specific EKG/ECG Changes	231	231
Purulent Discharge	224	224
Heart Block	223	223
Fall	222	222
Death	216	216
Therapeutic Effects, Unexpected	204	204
Asystole	172	172
Syncope	151	151
Muscle Weakness	134	134
Heart Failure/Congestive Heart Failure	110	110
Presyncope	106	106
No Code Available	106	106
Low Blood Pressure/ Hypotension	103	103
Device Overstimulation of Tissue	102	102
Ventricular Fibrillation	101	101
Drug Resistant Bacterial Infection	97	97
No Information	88	88
Foreign Body In Patient	82	82
Loss of consciousness	81	81
Hypersensitivity/Allergic reaction	75	75
Cardiomyopathy	73	73
Failure of Implant	61	61

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., Cardiac Rhythm and Heart Failure (CRHF)	II	Jul-10-2020
5	Medtronic, Inc.	II	Jun-06-2025
6	St Jude Medical, Cardiac Rhythm Management Division	II	Feb-24-2020
7	St. Jude Medical, Cardian Rhythm Management Division	I	May-07-2021