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)
2020	2021	2022	2023	2024	2025
11	8	6	12	14	4

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	817	817
Unexpected Therapeutic Results	254	254
Migration	118	118
High impedance	103	103
Charging Problem	59	59
Wireless Communication Problem	45	45
Battery Problem	44	44
Intermittent Energy Output	31	31
Inappropriate/Inadequate Shock/Stimulation	31	31
Inappropriate or Unexpected Reset	25	25
Use of Device Problem	23	23
Premature Discharge of Battery	22	22
Fracture	15	15
Defective Device	13	13
Overheating of Device	10	10
Low impedance	9	9
Delayed Charge Time	8	8
Device Displays Incorrect Message	7	7
Positioning Problem	7	7
Failure to Disconnect	6	6
Off-Label Use	6	6
Material Twisted/Bent	5	5
Power Problem	4	4
Difficult to Remove	4	4
Insufficient Information	4	4
Unintended Movement	4	4
Mechanical Problem	3	3
Difficult to Insert	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
Structural Problem	1	1
Environmental Compatibility Problem	1	1
Packaging Problem	1	1
Patient-Device Incompatibility	1	1
Material Separation	1	1
Defibrillation/Stimulation Problem	1	1
No Apparent Adverse Event	1	1
Application Program Problem	1	1
Malposition of Device	1	1
Defective Alarm	1	1
Computer Software Problem	1	1
Device Dislodged or Dislocated	1	1
Break	1	1
Appropriate Term/Code Not Available	1	1
Difficult to Open or Close	1	1
Unexpected Shutdown	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	303	303
Bacterial Infection	155	155
Unspecified Infection	152	152
No Code Available	126	126
Shaking/Tremors	116	116
Swelling/ Edema	104	104
Movement Disorder	82	82
Insufficient Information	74	74
Erosion	68	68
Inadequate Pain Relief	68	68
Pain	57	57
Undesired Nerve Stimulation	57	57
Impaired Healing	51	51
Discomfort	50	50
Wound Dehiscence	47	47
Convulsion/Seizure	46	46
Intracranial Hemorrhage	44	44
Confusion/ Disorientation	37	37
Speech Disorder	37	37
Hematoma	36	36
Fluid Discharge	32	32
Cognitive Changes	30	30
Purulent Discharge	28	28
Fall	28	28
Hemorrhage/Bleeding	27	27
Erythema	22	22
Muscle Weakness	22	22
Inflammation	21	21
Dyskinesia	21	21
Paralysis	18	18
Headache	16	16
Stroke/CVA	15	15
Skin Inflammation/ Irritation	14	14
Burning Sensation	13	13
Implant Pain	13	13
Pocket Erosion	12	12
Paresthesia	12	12
Unspecified Musculoskeletal problem	12	12
Abscess	11	11
Dysphasia	11	11
Fever	10	10
Dizziness	10	10
Failure of Implant	9	9
Hypersensitivity/Allergic reaction	9	9
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	9	9
Post Operative Wound Infection	8	8
Hemorrhage, Cerebral	8	8
Edema	8	8
Unspecified Mental, Emotional or Behavioural Problem	7	7
Scar Tissue	7	7

Recalls
Manufacturer		Recall Class	Date Posted
1	Boston Scientific Neuromodulation Corporation	II	May-24-2024
2	Boston Scientific Neuromodulation Corporation	II	May-26-2020