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	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	817	830
Unexpected Therapeutic Results	275	277
High impedance	114	118
Migration	104	104
Charging Problem	65	65
Battery Problem	56	56
Wireless Communication Problem	48	49
Inappropriate/Inadequate Shock/Stimulation	38	38
Intermittent Energy Output	31	31
Use of Device Problem	24	25
Premature Discharge of Battery	21	22
Inappropriate or Unexpected Reset	21	21
Fracture	17	17
Defective Device	13	14
Overheating of Device	11	11
Low impedance	10	10
Delayed Charge Time	9	9
Off-Label Use	8	8
Failure to Disconnect	6	6
Positioning Problem	6	6
Device Displays Incorrect Message	5	5
Appropriate Term/Code Not Available	5	5
Power Problem	4	5
Insufficient Information	4	4
Mechanical Problem	3	3
Difficult to Remove	3	3
Inadequate or Insufficient Training	2	2
Defibrillation/Stimulation Problem	2	2
Material Twisted/Bent	2	2
Difficult to Insert	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
Migration or Expulsion of Device	2	2
Environmental Compatibility Problem	1	1
Packaging Problem	1	1
Structural Problem	1	1
No Apparent Adverse Event	1	1
Impedance Problem	1	1
Defective Alarm	1	1
Computer Software Problem	1	1
Device Dislodged or Dislocated	1	1
Malposition of Device	1	1
Nonstandard Device	1	1
Pocket Stimulation	1	1
Difficult to Open or Close	1	1
Device Contaminated During Manufacture or Shipping	1	1
Unstable	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	327	331
Bacterial Infection	164	165
Swelling/ Edema	143	144
Unspecified Infection	139	140
Shaking/Tremors	125	126
Insufficient Information	111	111
Movement Disorder	100	102
Pain	75	76
Erosion	73	73
Undesired Nerve Stimulation	64	64
Inadequate Pain Relief	64	65
Inflammation	56	56
Discomfort	55	55
Wound Dehiscence	52	53
Impaired Healing	51	52
Convulsion/Seizure	50	52
Intracranial Hemorrhage	49	50
Fluid Discharge	43	43
Speech Disorder	43	45
Hemorrhage/Bleeding	36	37
Confusion/ Disorientation	34	35
Hematoma	34	35
Purulent Discharge	32	32
Fall	31	31
Erythema	30	30
Muscle Weakness	30	30
Cognitive Changes	29	29
Burning Sensation	26	26
Dyskinesia	24	26
Paralysis	16	16
Unspecified Musculoskeletal problem	16	17
Skin Inflammation/ Irritation	16	17
Headache	16	16
Implant Pain	15	16
Paresthesia	14	15
Pocket Erosion	12	12
Urinary Incontinence	12	12
Fever	12	12
Stroke/CVA	11	12
Dizziness	10	10
Hypersensitivity/Allergic reaction	10	11
Dysphasia	10	11
Abscess	9	9
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
Fatigue	7	7
Unspecified Mental, Emotional or Behavioural Problem	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