TPLC - Total Product Life Cycle

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Device	pacemaker/icd/crt non-implanted components
Definition	Pacemaker/ICD/CRT non-implanted components provide programming, interrogation, printing, remote monitoring, and communication between the pulse generator and the health care provider.
Product Code	OSR
Device Class	3

Premarket Approvals (PMA)
2009	2010	2011	2012	2013	2014	2015	2016	2017	2018	2019	2020	2021	2022	2023	2024
0	0	1	1	2	8	8	3	1	0	0	0	2	1	3	0

Device Problems	MDRs with this Device Problem	Events in those MDRs
Key or Button Unresponsive/not Working	861	861
Defective Device	595	595
Communication or Transmission Problem	394	394
Application Program Problem	100	100
Wireless Communication Problem	88	88
Display or Visual Feedback Problem	71	71
Device Operates Differently Than Expected	65	65
Failure to Power Up	63	63
Data Problem	48	48
Defective Component	35	35
Overheating of Device	32	32
Computer Software Problem	28	28
Power Problem	25	25
Interrogation Problem	23	23
Computer Operating System Problem	22	22
Detachment of Device or Device Component	22	22
No Apparent Adverse Event	22	22
No Display/Image	18	18
Pacing Problem	18	18
Connection Problem	17	17
Application Program Freezes, Becomes Nonfunctional	14	14
Telemetry Discrepancy	12	12
Device Displays Incorrect Message	9	9
Use of Device Problem	9	9
Inadequate User Interface	8	8
Incorrect Measurement	8	8
Device Sensing Problem	8	8
Material Integrity Problem	8	8
Battery Problem	7	7
Electrical /Electronic Property Problem	6	6
Adverse Event Without Identified Device or Use Problem	6	6
Insufficient Information	6	6
Inappropriate/Inadequate Shock/Stimulation	5	5
Failure to Transmit Record	5	5
Over-Sensing	5	5
Date/Time-Related Software Problem	5	5
Mechanical Problem	5	5
Failure to Interrogate	4	4
Ambient Noise Problem	4	4
Output Problem	4	4
Failure to Shut Off	4	4
Patient Data Problem	3	3
Smoking	3	3
Program or Algorithm Execution Failure	3	3
Device Packaging Compromised	3	3
Appropriate Term/Code Not Available	3	3
Device Operational Issue	3	3
Intermittent Loss of Power	3	3
Unexpected Shutdown	3	3
Noise, Audible	3	3

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1685	1685
No Known Impact Or Consequence To Patient	124	124
No Information	54	54
Insufficient Information	47	47
No Consequences Or Impact To Patient	45	45
No Patient Involvement	40	40
Asystole	10	10
Bradycardia	5	5
Syncope/Fainting	4	4
Unspecified Infection	3	3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	3	3
Arrhythmia	3	3
Complaint, Ill-Defined	3	3
Electric Shock	3	3
Syncope	2	2
Shock from Patient Lead(s)	2	2
Head Injury	2	2
Cardiac Arrest	2	2
Dyspnea	2	2
Fall	2	2
Heart Failure/Congestive Heart Failure	2	2
Tachycardia	2	2
Death	1	1
Failure of Implant	1	1
Dizziness	1	1
Atrial Fibrillation	1	1
Burn(s)	1	1
Fever	1	1
Ventricular Fibrillation	1	1
Discomfort	1	1
Cardiomyopathy	1	1
Swelling/ Edema	1	1
Atrial Flutter	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)	II	Nov-24-2021
2	Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)	II	Apr-30-2021
3	Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)	II	Mar-19-2020
4	Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)	II	Oct-30-2019
5	Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)	II	Feb-16-2019
6	Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)	II	Feb-02-2019
7	Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)	II	Nov-08-2018
8	St Jude Medical Inc.	II	Jun-29-2018
9	St Jude Medical Inc.	II	Jun-12-2018
10	St. Jude Medical, Cardiac Rhythm Management Division	II	Apr-21-2022