TPLC - Total Product Life Cycle

• Device: stimulator, electrical, implantable, for incontinence
• Regulation Description: Implanted electrical urinary continence device.
• Definition: PMAs to be filed by 12/26/96 (61 FR 50707 (9/27/96))
• Product Code: EZW
• Regulation Number: 876.5270
• Device Class: 3

Premarket Approvals (PMA)
2020	2021	2022	2023	2024	2025
43	34	46	32	35	14

MDR Year	MDR Reports	MDR Events
2020	4118	4118
2021	4479	4479
2022	4318	4318
2023	5056	5056
2024	5773	5773
2025	1548	1548

Device Problems	MDRs with this Device Problem	Events in those MDRs
Insufficient Information	6049	6049
Adverse Event Without Identified Device or Use Problem	5866	5866
Migration or Expulsion of Device	3825	3825
Failure to Deliver Energy	2796	2796
Inappropriate/Inadequate Shock/Stimulation	2556	2556
Energy Output Problem	2213	2213
Communication or Transmission Problem	2210	2210
Battery Problem	2175	2175
Break	1857	1857
Unintended Collision	1749	1749
Failure to Interrogate	1516	1516
Electromagnetic Compatibility Problem	1293	1293
High impedance	1202	1202
Therapy Delivered to Incorrect Body Area	1082	1082
Electromagnetic Interference	969	969
Malposition of Device	837	837
Patient Device Interaction Problem	718	718
Charging Problem	675	675
Unstable	451	451
Intermittent Continuity	445	445
Overheating of Device	425	425
Data Problem	389	389
Positioning Problem	361	361
Impedance Problem	356	356
Pocket Stimulation	308	308
Difficult to Remove	303	303
Connection Problem	292	292
Premature Discharge of Battery	288	288
Application Program Problem	206	206
Disconnection	196	196
Material Deformation	196	196
Therapeutic or Diagnostic Output Failure	180	180
Delayed Charge Time	167	167
Display or Visual Feedback Problem	139	139
Migration	127	127
Low impedance	96	96
Appropriate Term/Code Not Available	89	89
Vibration	86	86
Environmental Compatibility Problem	85	85
Human-Device Interface Problem	84	84
Failure to Power Up	72	72
No Device Output	64	64
Difficult to Insert	59	59
Loss of Data	56	56
Failure to Charge	49	49
Lack of Effect	45	45
Shipping Damage or Problem	40	40
Material Twisted/Bent	39	39
Improper or Incorrect Procedure or Method	38	38
Use of Device Problem	33	33

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	7888	7888
Insufficient Information	5940	5940
Pain	4857	4857
Incontinence	3132	3132
Electric Shock	2563	2563
Discomfort	2234	2234
Urinary Retention	1844	1844
Urinary Frequency	1465	1465
Unspecified Infection	1410	1410
Undesired Nerve Stimulation	1324	1324
No Known Impact Or Consequence To Patient	1039	1039
Therapeutic Effects, Unexpected	860	860
Burning Sensation	739	739
Device Embedded In Tissue or Plaque	683	683
Therapeutic Response, Decreased	661	661
Micturition Urgency	589	589
Device Overstimulation of Tissue	567	567
Complaint, Ill-Defined	519	519
Urinary Incontinence	417	417
Sleep Dysfunction	412	412
Hemorrhage/Bleeding	390	390
Ambulation Difficulties	382	382
Constipation	356	356
Diarrhea	299	299
Urinary Tract Infection	284	284
Cramp(s) /Muscle Spasm(s)	276	276
Swelling/ Edema	273	273
Failure of Implant	247	247
Dysuria	211	211
Paresthesia	195	195
Fluid Discharge	188	188
Numbness	187	187
Malaise	185	185
Wound Dehiscence	157	157
Pocket Erosion	153	153
Erythema	151	151
Itching Sensation	144	144
Scar Tissue	118	118
Fecal Incontinence	112	112
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	110	110
Weight Changes	106	106
Nausea	98	98
Bruise/Contusion	97	97
Bacterial Infection	89	89
Nerve Damage	85	85
Abdominal Pain	83	83
Skin Inflammation/ Irritation	81	81
Hypersensitivity/Allergic reaction	80	80
Impaired Healing	80	80
Inflammation	76	76

Recalls
Manufacturer		Recall Class	Date Posted
1	Medtronic Neuromodulation	II	Sep-06-2024
2	Medtronic Neuromodulation	II	Aug-10-2023
3	Medtronic Neuromodulation	II	Apr-22-2022
4	Medtronic Neuromodulation	II	Nov-24-2021