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)
2019	2020	2021	2022	2023	2024
60	73	40	44	39	23

MDR Year	MDR Reports	MDR Events
2019	8186	8186
2020	8337	8337
2021	8537	8537
2022	7791	7791
2023	8466	8466
2024	4394	4394

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	10682	10682
Premature Discharge of Battery	4935	4935
Pacing Problem	4773	4773
Appropriate Term/Code Not Available	3979	3979
Over-Sensing	3236	3236
Failure to Interrogate	2412	2412
Battery Problem	1979	1979
Mechanical Problem	1449	1449
Inappropriate or Unexpected Reset	1156	1156
Unable to Obtain Readings	1072	1072
Defective Device	1058	1058
Failure to Capture	984	984
Pacemaker Found in Back-Up Mode	954	954
Inappropriate/Inadequate Shock/Stimulation	938	938
Incorrect Measurement	884	884
Signal Artifact/Noise	814	814
Overheating of Device	736	736
Under-Sensing	685	685
Communication or Transmission Problem	616	616
Reset Problem	604	604
False Alarm	592	592
Incorrect Interpretation of Signal	495	495
Device Sensing Problem	478	478
Migration or Expulsion of Device	458	458
Electromagnetic Interference	444	444
Insufficient Information	431	431
No Pacing	426	426
High impedance	404	404
Low impedance	352	352
Data Problem	314	314
Premature Elective Replacement Indicator	278	278
Output Problem	272	272
Capturing Problem	271	271
Loose or Intermittent Connection	258	258
High Capture Threshold	210	210
Impedance Problem	198	198
Electrical /Electronic Property Problem	191	191
Misconnection	183	183
Failure to Deliver Shock/Stimulation	177	177
Failure to Disconnect	167	167
Failure to Charge	166	166
Use of Device Problem	152	152
Interrogation Problem	146	146
Break	132	132
Missing Test Results	126	126
Thermal Decomposition of Device	124	124
Protective Measures Problem	113	113
Failure to Convert Rhythm	101	101
Intermittent Capture	101	101
Incorrect, Inadequate or Imprecise Result or Readings	99	99

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	16885	16885
No Known Impact Or Consequence To Patient	7910	7913
Unspecified Infection	6808	6808
Insufficient Information	2133	2133
No Consequences Or Impact To Patient	2089	2089
Bradycardia	1844	1844
Arrhythmia	933	933
Dizziness	868	868
Syncope/Fainting	846	846
Discomfort	833	833
Pocket Erosion	812	812
Dyspnea	614	614
Death	573	573
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	501	501
Pain	493	493
Chest Pain	416	416
Therapeutic Effects, Unexpected	407	407
Bacterial Infection	402	402
Tachycardia	389	389
Erosion	377	377
Syncope	355	355
Fatigue	327	327
Cardiac Arrest	296	296
Sepsis	295	295
Endocarditis	263	263
Hematoma	258	258
Erythema	243	243
Atrial Fibrillation	241	241
Non specific EKG/ECG Changes	237	237
Fall	231	231
Wound Dehiscence	206	206
Swelling/ Edema	202	202
No Code Available	201	201
Heart Block	193	193
Fever	184	184
No Information	183	183
Complaint, Ill-Defined	143	143
Purulent Discharge	141	141
Asystole	136	136
Muscle Weakness	123	123
Ventricular Fibrillation	113	113
Palpitations	110	110
Low Blood Pressure/ Hypotension	105	105
Device Overstimulation of Tissue	86	86
Ventricular Tachycardia	83	83
Heart Failure/Congestive Heart Failure	82	82
Foreign Body In Patient	82	82
Presyncope	78	78
Loss of consciousness	73	73
Drug Resistant Bacterial Infection	68	68

Recalls
Manufacturer		Recall Class	Date Posted
1	Medtronic Inc.	II	Sep-13-2024
2	Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)	II	Dec-16-2021
3	Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)	II	Jul-10-2020
4	Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)	I	Feb-14-2019
5	St Jude Medical, Cardiac Rhythm Management Division	II	Feb-24-2020
6	St. Jude Medical, Cardian Rhythm Management Division	I	May-07-2021