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)
2019	2020	2021	2022	2023	2024
17	11	8	6	12	10

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	812	812
Unexpected Therapeutic Results	232	232
Migration	121	121
High impedance	84	84
Charging Problem	56	56
Wireless Communication Problem	40	40
Battery Problem	31	31
Inappropriate/Inadequate Shock/Stimulation	29	29
Intermittent Energy Output	24	24
Inappropriate or Unexpected Reset	21	21
Premature Discharge of Battery	21	21
Use of Device Problem	20	20
Fracture	17	17
Defective Device	14	14
Low impedance	10	10
Positioning Problem	9	9
Overheating of Device	8	8
Delayed Charge Time	8	8
Device Displays Incorrect Message	7	7
Material Twisted/Bent	5	5
Off-Label Use	5	5
Failure to Disconnect	5	5
Power Problem	4	4
Difficult to Remove	4	4
Unintended Movement	4	4
Insufficient Information	3	3
Difficult to Insert	2	2
Device Dislodged or Dislocated	2	2
Migration or Expulsion of Device	2	2
Communication or Transmission Problem	2	2
Mechanical Problem	2	2
Energy Output Problem	2	2
Inadequate or Insufficient Training	2	2
No Apparent Adverse Event	1	1
Defibrillation/Stimulation Problem	1	1
Material Separation	1	1
Patient-Device Incompatibility	1	1
Application Program Problem	1	1
Unexpected Shutdown	1	1
Unstable	1	1
Failure to Deliver Energy	1	1
Device Contaminated During Manufacture or Shipping	1	1
Human-Device Interface Problem	1	1
Break	1	1
Malposition of Device	1	1
Difficult to Open or Close	1	1
Appropriate Term/Code Not Available	1	1
Defective Alarm	1	1
Computer Software Problem	1	1
Environmental Compatibility Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	262	262
No Code Available	190	190
Unspecified Infection	159	159
Bacterial Infection	148	148
Shaking/Tremors	107	107
Swelling/ Edema	98	98
Movement Disorder	69	69
Inadequate Pain Relief	68	68
Erosion	67	67
Insufficient Information	59	59
Pain	57	57
Impaired Healing	50	50
Undesired Nerve Stimulation	49	49
Wound Dehiscence	44	44
Convulsion/Seizure	44	44
Discomfort	43	43
Intracranial Hemorrhage	40	40
Confusion/ Disorientation	36	36
Hematoma	36	36
Speech Disorder	34	34
Cognitive Changes	31	31
Fluid Discharge	31	31
Hemorrhage/Bleeding	29	29
Purulent Discharge	28	28
Fall	25	25
Muscle Weakness	22	22
Inflammation	21	21
Paralysis	20	20
Dyskinesia	18	18
Stroke/CVA	15	15
Headache	15	15
Edema	15	15
Abscess	14	14
Seizures	12	12
Skin Inflammation/ Irritation	12	12
Implant Pain	12	12
Erythema	12	12
Burning Sensation	12	12
Fever	12	12
Unspecified Musculoskeletal problem	11	11
Dysphasia	11	11
Dizziness	10	10
Pocket Erosion	10	10
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	10	10
Paresthesia	10	10
Hypersensitivity/Allergic reaction	9	9
Hemorrhage, Cerebral	9	9
Staphylococcus Aureus	9	9
Emotional Changes	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