TPLC - Total Product Life Cycle

• Device: agent, bulking, injectable for gastro-urology use
• Product Code: LNM
• Device Class: 3

Premarket Approvals (PMA)
2009	2010	2011	2012	2013	2014	2015	2016	2017	2018	2019	2020	2021	2022	2023	2024
18	9	10	12	12	16	7	3	7	7	10	23	5	13	14	2

MDR Year	MDR Reports	MDR Events
2014	52	52
2015	58	58
2016	71	71
2017	86	86
2018	36	36
2019	8	8
2020	7	7
2021	11	11
2022	18	18
2023	16	16
2024	9	9

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	256	256
Insufficient Information	30	30
Appropriate Term/Code Not Available	12	12
Migration or Expulsion of Device	10	10
Patient-Device Incompatibility	9	9
Material Erosion	8	8
Device Operates Differently Than Expected	7	7
Unexpected Therapeutic Results	6	6
Improper or Incorrect Procedure or Method	4	4
Break	4	4
No Apparent Adverse Event	4	4
Malposition of Device	3	3
Calcified	3	3
Difficult to Remove	3	3
Incorrect, Inadequate or Imprecise Result or Readings	2	2
Shelf Life Exceeded	1	1
Use of Device Problem	1	1
Obstruction of Flow	1	1
Defective Device	1	1
Contamination /Decontamination Problem	1	1
Detachment Of Device Component	1	1
Entrapment of Device	1	1
Burst Container or Vessel	1	1
Bent	1	1
Off-Label Use	1	1
Positioning Problem	1	1
Device Operational Issue	1	1
Difficult to Advance	1	1
Device Contamination with Chemical or Other Material	1	1
No Flow	1	1
Patient Device Interaction Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Incontinence	117	117
Urinary Tract Infection	83	83
Pain	76	76
Unspecified Infection	58	58
Micturition Urgency	57	57
Injury	48	48
Erosion	39	39
Obstruction/Occlusion	33	33
Urinary Frequency	31	31
Urinary Retention	27	27
Prolapse	20	20
Dysuria	20	20
Inflammation	19	19
Hematuria	18	18
Blood Loss	17	17
Internal Organ Perforation	12	12
No Code Available	12	12
Calcium Deposits/Calcification	11	11
No Known Impact Or Consequence To Patient	10	10
Test Result	10	10
Abscess	9	9
Itching Sensation	9	9
Hemorrhage/Bleeding	8	8
Abdominal Pain	8	8
Abdominal Distention	8	8
Discomfort	8	8
Scar Tissue	8	8
Sepsis	6	6
Fever	6	6
Foreign Body In Patient	6	6
Constipation	5	5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	5	5
Hematoma	5	5
Hypersensitivity/Allergic reaction	5	5
Rash	5	5
Swelling	5	5
Abnormal Vaginal Discharge	5	5
Chills	5	5
Stenosis	5	5
Complaint, Ill-Defined	4	4
Renal Failure	4	4
Scarring	4	4
Muscle Spasm(s)	4	4
Failure of Implant	4	4
Granuloma	4	4
Adhesion(s)	4	4
Cyst(s)	4	4
No Information	4	4
No Clinical Signs, Symptoms or Conditions	3	3
Urinary Incontinence	3	3
Insufficient Information	3	3
Diarrhea	3	3
Nausea	3	3
Discharge	3	3
Vomiting	3	3
Therapeutic Response, Decreased	3	3
Depression	2	2
Reaction	2	2
Vaginal Mucosa Damage	2	2
Myalgia	2	2
Regurgitation	2	2
Septic Shock	2	2
Liver Damage/Dysfunction	2	2
Foreign Body Reaction	2	2
Erythema	2	2
Fibrosis	2	2
Unspecified Kidney or Urinary Problem	2	2
Genital Bleeding	2	2
Renal Impairment	2	2
Urethral Stenosis/Stricture	1	1
Patient Problem/Medical Problem	1	1
Fluid Discharge	1	1
Subcutaneous Nodule	1	1
Fistula	1	1
Headache	1	1
Dysphagia/ Odynophagia	1	1
Death	1	1
Deposits	1	1
Bacterial Infection	1	1
Cellulitis	1	1
Irritation	1	1
Necrosis	1	1
Muscular Rigidity	1	1
Raynauds Phenomenon	1	1
Overdose	1	1
Tissue Damage	1	1
Rupture	1	1
Weakness	1	1
Numbness	1	1
Reaction, Injection Site	1	1
Ambulation Difficulties	1	1
Disability	1	1
Malaise	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Axonics Modulation Technologies, Inc.	II	Jul-15-2021
2	Merz North America, Inc.	II	Nov-16-2020