TPLC - Total Product Life Cycle

show TPLC since

Device	implanted tibial electrical urinary continence device
Definition	An implanted tibial electrical urinary continence device is an implanted prescription device that receives power from a non-implanted external power source to provide electrical stimulation of the tibial nerve in proximity to the ankle. The device is intended for the treatment of overactive bladder related symptoms of urge urinary incontinence, urinary urgency, urinary frequency and nocturia.
Product Code	QXM
Regulation Number	876.5305
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	22	22
Defibrillation/Stimulation Problem	2	2
Patient-Device Incompatibility	1	1
Electrical Shorting	1	1
Failure to Interrogate	1	1
Defective Device	1	1
Continuous Firing	1	1
Overheating of Device	1	1
Intermittent Continuity	1	1
Failure to Deliver Shock/Stimulation	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Post Operative Wound Infection	8	8
Undesired Nerve Stimulation	5	5
Implant Pain	4	4
Swelling/ Edema	2	2
No Clinical Signs, Symptoms or Conditions	2	2
Insufficient Information	2	2
Peripheral Edema	2	2
Skin Inflammation/ Irritation	1	1
Urinary Incontinence	1	1
Discomfort	1	1
Skin Burning Sensation	1	1
Electric Shock	1	1
Neuropathy	1	1
Granuloma	1	1
Pain	1	1