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)
2018	2019	2020	2021	2022	2023	2024	2025	2026
6	17	11	8	6	12	14	10	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	1018	1033
Unexpected Therapeutic Results	322	324
High impedance	136	140
Migration	135	135
Charging Problem	78	78
Battery Problem	60	60
Wireless Communication Problem	58	59
Inappropriate/Inadequate Shock/Stimulation	40	40
Intermittent Energy Output	34	34
Use of Device Problem	32	33
Premature Discharge of Battery	27	28
Fracture	26	26
Inappropriate or Unexpected Reset	21	21
Defective Device	15	16
Low impedance	12	12
Overheating of Device	12	12
Off-Label Use	11	11
Delayed Charge Time	10	10
Positioning Problem	10	10
Appropriate Term/Code Not Available	7	7
Failure to Disconnect	7	7
Device Displays Incorrect Message	7	7
Nonstandard Device	6	6
Migration or Expulsion of Device	5	5
Material Twisted/Bent	5	5
Power Problem	5	6
Unintended Movement	4	4
Insufficient Information	4	4
Difficult to Remove	4	4
Mechanical Problem	3	3
Communication or Transmission Problem	3	3
Device Dislodged or Dislocated	2	2
No Apparent Adverse Event	2	2
Therapeutic or Diagnostic Output Failure	2	2
Energy Output Problem	2	2
Difficult to Insert	2	2
Malposition of Device	2	2
Patient-Device Incompatibility	2	2
Defibrillation/Stimulation Problem	2	2
Device Issue	2	2
Inadequate or Insufficient Training	2	2
Unstable	1	1
Failure to Read Input Signal	1	1
Structural Problem	1	1
Application Program Problem	1	1
Defective Alarm	1	1
Break	1	1
Computer Software Problem	1	1
Failure to Deliver Energy	1	1
Material Separation	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	343	347
No Code Available	198	198
Bacterial Infection	195	196
Unspecified Infection	180	181
Swelling/ Edema	151	152
Shaking/Tremors	136	137
Insufficient Information	117	117
Movement Disorder	104	107
Pain	90	91
Erosion	87	87
Undesired Nerve Stimulation	73	73
Inadequate Pain Relief	70	71
Discomfort	65	65
Wound Dehiscence	62	63
Impaired Healing	61	62
Inflammation	57	57
Intracranial Hemorrhage	52	54
Fluid Discharge	51	51
Convulsion/Seizure	50	52
Confusion/ Disorientation	46	47
Speech Disorder	45	48
Hemorrhage/Bleeding	44	45
Hematoma	44	45
Purulent Discharge	39	39
Fall	37	37
Cognitive Changes	33	34
Erythema	32	32
Muscle Weakness	31	31
Burning Sensation	30	30
Dyskinesia	29	31
Edema	22	22
Paralysis	22	22
Headache	20	20
Unspecified Musculoskeletal problem	18	19
Fever	16	16
Skin Inflammation/ Irritation	16	17
Seizures	15	15
Abscess	15	15
Implant Pain	15	16
Stroke/CVA	15	16
Paresthesia	14	15
Pocket Erosion	14	14
Urinary Incontinence	12	12
Hypersensitivity/Allergic reaction	12	13
Dysphasia	12	13
Emotional Changes	11	11
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	11	11
No Known Impact Or Consequence To Patient	11	11
Dizziness	10	10
Hemorrhage, Cerebral	10	11

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
4	Boston Scientific Neuromodulation Corporation	II	May-26-2020