TPLC - Total Product Life Cycle

• Device: implanted brain stimulator for epilepsy
• Definition: For the treatment of epilepsy.
• Product Code: PFN
• Device Class: 3

Premarket Approvals (PMA)
2009	2010	2011	2012	2013	2014	2015	2016	2017	2018	2019	2020	2021	2022	2023	2024
0	0	0	0	3	22	13	8	4	10	12	8	3	3	4	0

MDR Year	MDR Reports	MDR Events
2014	15	15
2015	36	36
2016	28	28
2017	63	63
2018	54	54
2019	59	59
2020	66	66
2021	57	57
2022	49	49
2023	67	67
2024	31	31

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	379	379
Signal Artifact/Noise	48	48
Break	33	33
Impedance Problem	29	29
High impedance	27	27
Failure to Interrogate	25	25
Communication or Transmission Problem	19	19
Insufficient Information	19	19
Premature Discharge of Battery	8	8
Appropriate Term/Code Not Available	7	7
Failure to Transmit Record	6	6
Device Remains Activated	5	5
Fracture	5	5
Battery Problem	3	3
Deformation Due to Compressive Stress	2	2
Positioning Problem	2	2
Therapeutic or Diagnostic Output Failure	2	2
Unexpected Therapeutic Results	2	2
Under-Sensing	1	1
Improper or Incorrect Procedure or Method	1	1
Low impedance	1	1
Dent in Material	1	1
Material Fragmentation	1	1
Material Separation	1	1
Electrical /Electronic Property Problem	1	1
Material Erosion	1	1
Leak/Splash	1	1
Mechanical Problem	1	1
Migration or Expulsion of Device	1	1
Off-Label Use	1	1
Missing Value Reason	1	1
Migration	1	1
Programming Issue	1	1
Installation-Related Problem	1	1
Mechanics Altered	1	1
Loss of Data	1	1
Detachment of Device or Device Component	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Bacterial Infection	122	122
Unspecified Infection	114	114
No Consequences Or Impact To Patient	52	52
No Clinical Signs, Symptoms or Conditions	52	52
Wound Dehiscence	47	47
Fluid Discharge	38	38
Erosion	37	37
Impaired Healing	27	27
Purulent Discharge	24	24
Pain	21	21
Hemorrhage/Bleeding	20	20
Headache	19	19
Drug Resistant Bacterial Infection	17	17
Hematoma	16	16
Skin Erosion	13	13
Intracranial Hemorrhage	12	12
No Known Impact Or Consequence To Patient	11	11
No Code Available	10	10
Discharge	10	10
Edema	9	9
Swelling/ Edema	8	8
Fever	7	7
Seizures	7	7
Staphylococcus Aureus	6	6
Discomfort	6	6
Head Injury	6	6
Post Operative Wound Infection	6	6
Muscle Weakness	5	5
Stroke/CVA	5	5
Cerebrospinal Fluid Leakage	5	5
Swelling	5	5
Injury	4	4
Hemorrhage, Subdural	4	4
Fall	3	3
Emotional Changes	3	3
Sleep Dysfunction	3	3
Visual Impairment	3	3
Weakness	3	3
Patient Problem/Medical Problem	3	3
Hydrocephalus	3	3
Cerebral Edema	3	3
Convulsion/Seizure	3	3
Speech Disorder	3	3
Twiddlers Syndrome	3	3
Test Result	2	2
No Information	2	2
Nodule	2	2
Tissue Damage	2	2
Neuropathy	2	2
Confusion/ Disorientation	2	2
Therapeutic Response, Decreased	2	2
Skin Discoloration	2	2
Concussion	2	2
Cellulitis	2	2
Abscess	2	2
Inflammation	2	2
Irritation	1	1
Itching Sensation	1	1
Nausea	1	1
Necrosis	1	1
Undesired Nerve Stimulation	1	1
Hemorrhage, Intraventricular	1	1
Hemorrhage, Cerebral	1	1
Erythema	1	1
Feeding Problem	1	1
Cyst(s)	1	1
Fistula	1	1
Flashers	1	1
Foreign Body Reaction	1	1
Rupture	1	1
Convulsion, Tonic	1	1
Hypoesthesia	1	1
Abdominal Distention	1	1
Weight Changes	1	1
Tissue Breakdown	1	1
Numbness	1	1
Fungal Infection	1	1
Neck Pain	1	1
Sweating	1	1
Paresis	1	1
Rash	1	1
Increased Sensitivity	1	1
Sepsis	1	1
Skin Irritation	1	1
Twiddlers Syndrome	1	1
Blurred Vision	1	1
Therapeutic Effects, Unexpected	1	1
Thrombosis	1	1
Tingling	1	1
Chills	1	1
Loss of Vision	1	1
Visual Disturbances	1	1
Device Embedded In Tissue or Plaque	1	1
Hemorrhagic Stroke	1	1
Unspecified Mental, Emotional or Behavioural Problem	1	1
Thrombosis/Thrombus	1	1
Eye Pain	1	1
Osteomyelitis	1	1
Peripheral Nervous Injury	1	1
Post Traumatic Wound Infection	1	1