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	4

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	835	848
Unexpected Therapeutic Results	288	290
High impedance	121	125
Migration	107	107
Charging Problem	69	69
Battery Problem	62	62
Wireless Communication Problem	53	54
Inappropriate/Inadequate Shock/Stimulation	40	40
Intermittent Energy Output	34	34
Use of Device Problem	28	29
Premature Discharge of Battery	24	25
Fracture	23	23
Inappropriate or Unexpected Reset	21	21
Off-Label Use	14	14
Defective Device	13	14
Overheating of Device	12	12
Low impedance	10	10
Delayed Charge Time	9	9
Appropriate Term/Code Not Available	8	8
Failure to Disconnect	7	7
Nonstandard Device	7	7
Positioning Problem	6	6
Device Displays Incorrect Message	5	5
Power Problem	5	6
Insufficient Information	4	4
Difficult to Remove	3	3
Mechanical Problem	3	3
Material Twisted/Bent	2	2
Difficult to Insert	2	2
Defibrillation/Stimulation Problem	2	2
Therapeutic or Diagnostic Output Failure	2	2
Unintended Movement	2	2
Patient-Device Incompatibility	2	2
Energy Output Problem	2	2
Communication or Transmission Problem	2	2
Inadequate or Insufficient Training	2	2
Migration or Expulsion of Device	2	2
Impedance Problem	1	1
Patient Device Interaction Problem	1	1
Structural Problem	1	1
Environmental Compatibility Problem	1	1
Packaging Problem	1	1
No Apparent Adverse Event	1	1
Defective Alarm	1	1
Computer Software Problem	1	1
Device Dislodged or Dislocated	1	1
Malposition of Device	1	1
Pocket Stimulation	1	1
Difficult to Open or Close	1	1
Device Contaminated During Manufacture or Shipping	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	341	345
Bacterial Infection	173	174
Swelling/ Edema	145	146
Unspecified Infection	140	141
Shaking/Tremors	131	132
Insufficient Information	117	117
Movement Disorder	103	105
Pain	77	78
Erosion	76	76
Undesired Nerve Stimulation	69	69
Inadequate Pain Relief	64	65
Discomfort	57	57
Inflammation	57	57
Wound Dehiscence	55	56
Intracranial Hemorrhage	51	52
Impaired Healing	51	52
Convulsion/Seizure	51	53
Speech Disorder	44	46
Fluid Discharge	44	44
Hemorrhage/Bleeding	38	39
Confusion/ Disorientation	36	37
Purulent Discharge	35	35
Hematoma	35	36
Fall	33	33
Erythema	32	32
Muscle Weakness	30	30
Cognitive Changes	29	29
Burning Sensation	28	28
Dyskinesia	26	28
Unspecified Musculoskeletal problem	18	19
Paralysis	17	17
Skin Inflammation/ Irritation	16	17
Headache	16	16
Implant Pain	15	16
Paresthesia	14	15
Pocket Erosion	13	13
Urinary Incontinence	12	12
Fever	12	12
Stroke/CVA	11	12
Dysphasia	11	12
Dizziness	10	10
Abscess	10	10
Hypersensitivity/Allergic reaction	10	11
Scar Tissue	9	9
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	9	9
Failure of Implant	8	8
Emotional Changes	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