TPLC - Total Product Life Cycle

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Device	stimulator, electrical, implanted, for parkinsonian symptoms
Definition	Bilateral stimulation of the internal globus pallidus (GPi) or the subthalamic nucleus (STN) using Medtronic Activa Parkinson's Control Therapy is indicated for adjunctive therapy in reducing some of the symptoms of advanced, levodopa-responsive Parkinsons disease that are not adequately controlled with medication.
Product Code	NHL
Device Class	3

Premarket Approvals (PMA)
2021	2022	2023	2024	2025	2026
8	6	12	14	10	5

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	833	845
Unexpected Therapeutic Results	291	293
High impedance	127	131
Migration	107	107
Charging Problem	67	67
Battery Problem	61	61
Wireless Communication Problem	54	55
Inappropriate/Inadequate Shock/Stimulation	41	41
Intermittent Energy Output	34	34
Use of Device Problem	29	30
Premature Discharge of Battery	27	28
Fracture	25	25
Inappropriate or Unexpected Reset	21	21
Off-Label Use	14	14
Defective Device	13	14
Delayed Charge Time	12	12
Overheating of Device	11	11
Low impedance	10	10
Appropriate Device Problem Term/Code Not Available	9	9
Failure to Disconnect	7	7
Nonstandard Device	7	7
Positioning Problem	6	6
Power Problem	5	6
Device Displays Incorrect Message	5	5
Mechanical Problem	3	3
Difficult to Remove	3	3
Erratic or Intermittent Display	3	3
Defective Component	3	3
Unintended Movement	2	2
Insufficient Device Problem Information	2	2
Material Twisted/Bent	2	2
Inadequate or Insufficient Training	2	2
Difficult to Insert	2	2
Packaging Problem	1	1
No Apparent Adverse Event	1	1
Device Contaminated During Manufacture or Shipping	1	1
Impedance Problem	1	1
Human-Device Interface Problem	1	1
Migration or Expulsion of Device	1	1
Device Dislodged or Dislocated	1	1
Energy Output Problem	1	1
Difficult to Open or Close	1	1
Extracardiac stimulation	1	1
Communication or Transmission Problem	1	1
Defective Alarm	1	1
Structural Problem	1	1
Failure to Deliver Energy	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	342	346
Bacterial Infection	176	177
Swelling/ Edema	147	148
Unspecified Infection	140	141
Shaking/Tremors	138	139
Insufficient Information	119	119
Movement Disorder	106	108
Pain	81	82
Erosion	77	77
Undesired Nerve Stimulation	69	69
Inadequate Pain Relief	64	65
Inflammation	57	57
Discomfort	57	57
Wound Dehiscence	55	56
Convulsion/Seizure	52	54
Intracranial Hemorrhage	52	53
Impaired Healing	51	52
Speech Disorder	45	47
Fluid Discharge	44	44
Hemorrhage/Blood Loss/Bleeding	41	42
Confusion/ Disorientation	36	37
Hematoma	36	37
Purulent Discharge	35	35
Fall	34	34
Erythema	32	32
Muscle Weakness/Atrophy	30	30
Cognitive Changes	29	29
Burning Sensation	28	28
Dyskinesia	26	28
Unspecified Musculoskeletal problem	20	21
Headache	19	19
Paralysis	18	18
Skin Inflammation/ Irritation	17	18
Implant Pain	15	16
Paresthesia	14	15
Pocket Erosion	13	13
Fever	12	12
Urinary Incontinence	12	12
Emotional Changes	11	11
Stroke/CVA	11	12
Dysphasia	11	12
Hypersensitivity/Allergic reaction	10	11
Dizziness	10	10
Abscess	10	10
Scar Tissue	9	9
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	9	9
Failure of Implant	8	8
Post Operative Wound Infection	8	8
Balance Problems	7	7
Fatigue	7	7

Recalls
Manufacturer		Recall Class	Date Posted
1	Boston Scientific Neuromodulation Corporation	II	Sep-12-2025
2	Boston Scientific Neuromodulation Corporation	II	Aug-19-2025
3	Boston Scientific Neuromodulation Corporation	II	May-24-2024