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	36

MDR Year	MDR Reports	MDR Events
2020	8337	8337
2021	8538	8540
2022	7791	7791
2023	8463	8463
2024	6496	6496
2025	5170	5170

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	11169	11169
Premature Discharge of Battery	4974	4974
Pacing Problem	4902	4902
Appropriate Term/Code Not Available	3389	3389
Over-Sensing	2995	2995
Failure to Interrogate	2483	2483
Mechanical Problem	1599	1599
Battery Problem	1234	1234
Defective Device	1149	1149
Inappropriate or Unexpected Reset	1040	1040
Failure to Capture	992	992
Pacemaker Found in Back-Up Mode	885	885
Unable to Obtain Readings	862	862
Inappropriate/Inadequate Shock/Stimulation	835	835
False Alarm	785	785
Signal Artifact/Noise	739	739
Incorrect Measurement	699	699
Overheating of Device	659	659
Under-Sensing	658	658
Reset Problem	629	629
Communication or Transmission Problem	563	563
Migration or Expulsion of Device	532	532
Electromagnetic Interference	488	488
Insufficient Information	469	469
Incorrect Interpretation of Signal	452	452
No Pacing	445	445
Device Sensing Problem	409	410
High impedance	373	373
Low impedance	334	334
Loose or Intermittent Connection	320	320
Premature Elective Replacement Indicator	290	290
Capturing Problem	276	276
Data Problem	246	246
Output Problem	242	242
Electrical /Electronic Property Problem	210	210
Failure to Disconnect	202	202
High Capture Threshold	189	189
Misconnection	183	183
Impedance Problem	168	168
Interrogation Problem	160	160
Use of Device Problem	155	155
Failure to Deliver Shock/Stimulation	151	151
Thermal Decomposition of Device	146	146
Failure to Charge	129	129
Break	121	122
Pacing Asynchronously	109	109
Missing Test Results	108	108
Intermittent Capture	105	105
Difficult to Remove	102	102
Therapeutic or Diagnostic Output Failure	101	102

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	20669	20669
Unspecified Infection	6953	6953
No Known Impact Or Consequence To Patient	2727	2727
Insufficient Information	2475	2475
Bradycardia	2111	2111
No Consequences Or Impact To Patient	2085	2085
Arrhythmia	1081	1081
Syncope/Fainting	1056	1056
Discomfort	1014	1015
Dizziness	874	874
Pocket Erosion	831	831
Dyspnea	634	634
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	612	612
Pain	597	597
Bacterial Infection	534	534
Erosion	499	499
Tachycardia	479	479
Erythema	476	476
Chest Pain	442	442
Swelling/ Edema	371	371
Fatigue	355	355
Sepsis	332	332
Endocarditis	294	294
Atrial Fibrillation	288	288
Purulent Discharge	288	288
Wound Dehiscence	282	282
Fever	279	279
Cardiac Arrest	277	277
Hematoma	262	262
Non specific EKG/ECG Changes	241	241
Fall	235	235
Heart Block	232	232
Death	216	216
Therapeutic Effects, Unexpected	204	204
Asystole	187	187
Syncope	151	151
Muscle Weakness	142	142
Heart Failure/Congestive Heart Failure	136	136
Drug Resistant Bacterial Infection	127	127
Presyncope	116	116
Device Overstimulation of Tissue	110	110
Low Blood Pressure/ Hypotension	106	106
No Code Available	106	106
Ventricular Fibrillation	103	103
Loss of consciousness	91	92
No Information	88	88
Cardiomyopathy	83	83
Foreign Body In Patient	82	82
Hypersensitivity/Allergic reaction	81	81
Fluid Discharge	66	66

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	Jul-23-2025
6	Medtronic, Inc.	II	Jun-06-2025
7	St Jude Medical, Cardiac Rhythm Management Division	II	Feb-24-2020
8	St. Jude Medical, Cardian Rhythm Management Division	I	May-07-2021