TPLC - Total Product Life Cycle

• Device: stimulator, autonomic nerve, implanted for stroke rehabilitation
• Definition: Stimulation of the vagus nerve
• Product Code: QPY
• Device Class: 3

Premarket Approvals (PMA)
2020	2021	2022	2023	2024	2025	2026
0	1	1	0	2	4	6

MDR Year	MDR Reports	MDR Events
2023	4	4
2024	5	5
2025	6	6
2026	31	31

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	31	31
High impedance	3	3
Insufficient Device Problem Information	2	2
No Apparent Adverse Event	2	2
Use of Device Problem	2	2
Patient Device Interaction Problem	1	1
Patient-Device Incompatibility	1	1
Loose or Intermittent Connection	1	1
Lack of Effect	1	1
Unintended Movement	1	1
Migration	1	1
Failure to Deliver Shock/Stimulation	1	1
Appropriate Device Problem Term/Code Not Available	1	1
Incomplete or Inadequate Connection	1	1
Low impedance	1	1
Device-Device Incompatibility	1	1
Failure to Interrogate	1	1
Misconnection	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	7	7
Medical device site infection	7	7
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	7	7
Implant Pain	4	4
Discomfort	3	3
Convulsion/Seizure	3	3
Voice alteration	3	3
Electric Shock	2	2
Post Operative Wound Infection	2	2
Dysphagia/ Odynophagia	2	2
Paresis	2	2
Unspecified Infection	2	2
Cough	2	2
Loss of consciousness	1	1
Aspiration/Inhalation	1	1
Neck Pain	1	1
Impaired Healing	1	1
Fall	1	1
Muscle Weakness/Atrophy	1	1
Dizziness	1	1
Unspecified Musculoskeletal problem	1	1
Hematoma	1	1
Tissue Breakdown	1	1
Insufficient Information	1	1
Nerve Damage	1	1
Balance Problems	1	1
Pneumonia	1	1