TPLC - Total Product Life Cycle

show TPLC since

Device	dorsal root ganglion stimulator for pain relief
Definition	Stimulation of the dorsal root ganglion for the treatment of chronic, intractable pain of the lower limbs.
Product Code	PMP
Device Class	3

Premarket Approvals (PMA)
2020	2021	2022	2023	2024	2025
8	13	3	9	13	4

Device Problems	MDRs with this Device Problem	Events in those MDRs
Migration	3484	3484
Therapeutic or Diagnostic Output Failure	1764	1764
Adverse Event Without Identified Device or Use Problem	1633	1633
High impedance	1623	1623
Fracture	1201	1201
Insufficient Information	297	297
Material Fragmentation	279	279
Use of Device Problem	274	274
Battery Problem	229	229
Wireless Communication Problem	221	221
Impedance Problem	166	166
Inappropriate/Inadequate Shock/Stimulation	105	105
Patient-Device Incompatibility	82	82
Disconnection	78	78
Low impedance	73	73
Failure to Deliver Energy	65	65
No Apparent Adverse Event	53	53
Break	48	48
Improper or Incorrect Procedure or Method	32	32
Therapy Delivered to Incorrect Body Area	29	29
Separation Failure	26	26
Material Twisted/Bent	21	21
Premature Elective Replacement Indicator	18	18
Material Split, Cut or Torn	17	17
Migration or Expulsion of Device	16	16
Temperature Problem	15	15
Difficult to Remove	13	13
Pocket Stimulation	13	13
Mechanical Jam	12	12
Failure to Advance	12	12
Unexpected Shutdown	10	10
Difficult to Insert	9	9
Intermittent Energy Output	7	7
Incomplete or Inadequate Connection	4	4
Failure to Disconnect	3	3
Premature Discharge of Battery	3	3
Material Separation	3	3
Energy Output Problem	3	3
Material Protrusion/Extrusion	2	2
Device Damaged by Another Device	2	2
Naturally Worn	2	2
Positioning Problem	2	2
Entrapment of Device	2	2
Material Frayed	2	2
Device Handling Problem	1	1
Charging Problem	1	1
Product Quality Problem	1	1
Detachment of Device or Device Component	1	1
Device Contamination with Chemical or Other Material	1	1
Device Misassembled During Manufacturing /Shipping	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Inadequate Pain Relief	7887	7887
Failure of Implant	942	942
No Clinical Signs, Symptoms or Conditions	786	786
Implant Pain	579	579
No Consequences Or Impact To Patient	253	253
Undesired Nerve Stimulation	240	240
Post Operative Wound Infection	211	211
Pain	170	170
Cerebrospinal Fluid Leakage	153	153
Unspecified Infection	151	151
Insufficient Information	150	150
Foreign Body In Patient	146	146
Device Embedded In Tissue or Plaque	98	98
Wound Dehiscence	82	82
Discomfort	75	75
Headache	73	73
Erosion	66	66
No Known Impact Or Consequence To Patient	58	58
Numbness	51	51
Muscle Weakness	37	37
Fluid Discharge	35	35
Burning Sensation	29	29
Scar Tissue	28	28
Cramp(s) /Muscle Spasm(s)	23	23
Hematoma	22	22
Fever	18	18
Vomiting	16	16
Skin Erosion	16	16
Hypersensitivity/Allergic reaction	15	15
Bacterial Infection	14	14
Fall	13	13
Twiddlers Syndrome	12	12
Movement Disorder	12	12
Nausea	11	11
Swelling/ Edema	11	11
Headache, Lumbar Puncture	11	11
Seroma	10	10
Decreased Respiratory Rate	10	10
Cardiac Arrest	9	9
Device Overstimulation of Tissue	7	7
Purulent Discharge	7	7
No Information	7	7
Death	6	6
Skin Inflammation/ Irritation	6	6
Convulsion/Seizure	6	6
Twiddlers Syndrome	5	5
Sepsis	5	5
Respiratory Arrest	5	5
Swelling	5	5
Incontinence	5	5

Recalls
Manufacturer		Recall Class	Date Posted
1	Abbott Medical	II	Jul-16-2024