TPLC - Total Product Life Cycle

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Device	active implantable bone conduction hearing system
Definition	An active implantable bone conduction hearing system is a prescription device consisting of an implanted transducer, implanted electronics components, and an audio processor. The active implantable bone conduction hearing system is intended to compensate for conductive or mixed hearing losses by conveying amplified acoustic signals to the cochlea via mechanical vibrations on the skull bone.
Product Code	PFO
Regulation Number	874.3340
Device Class	2

Premarket Reviews
Manufacturer	Decision
COCHLEAR
	SUBSTANTIALLY EQUIVALENT	1
COCHLEAR AMERICAS
	SUBSTANTIALLY EQUIVALENT	4
MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH
	SUBSTANTIALLY EQUIVALENT	4
	GRANTED	1
OTICON MEDICAL AB
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Appropriate Term/Code Not Available	743	743
Expulsion	320	320
Adverse Event Without Identified Device or Use Problem	190	190
No Device Output	95	95
Output Problem	74	74
Insufficient Information	65	65
Device Appears to Trigger Rejection	55	55
Device Dislodged or Dislocated	45	45
Patient Device Interaction Problem	29	29
Loss of Osseointegration	19	19
Unexpected Therapeutic Results	12	12
No Apparent Adverse Event	11	11
Improper or Incorrect Procedure or Method	9	9
Signal Artifact/Noise	8	8
Migration	8	8
Malposition of Device	8	8
Inadequacy of Device Shape and/or Size	6	6
Positioning Failure	5	5
Device Handling Problem	5	5
Loose or Intermittent Connection	4	4
Migration or Expulsion of Device	4	4
Lack of Effect	4	4
Microbial Contamination of Device	3	3
Failure to Read Input Signal	3	3
Therapeutic or Diagnostic Output Failure	3	3
Material Protrusion/Extrusion	3	3
Noise, Audible	3	3
Activation, Positioning or Separation Problem	2	2
Intermittent Shock/Stimulation	2	2
Circuit Failure	1	1
Device Damaged Prior to Use	1	1
Energy Output Problem	1	1
Osseointegration Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Unspecified Infection	446	446
Tissue Breakdown	303	303
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	222	222
Wound Dehiscence	174	174
Failure of Implant	169	169
No Clinical Signs, Symptoms or Conditions	111	111
Pain	100	100
Skin Infection	67	67
Post Operative Wound Infection	62	62
Insufficient Information	56	56
Necrosis	44	44
Hematoma	40	40
Swelling/ Edema	37	37
Bacterial Infection	36	36
Fluid Discharge	33	33
Implant Pain	30	30
Skin Inflammation/ Irritation	24	24
Abscess	24	24
Impaired Healing	23	23
Skin Tears	21	21
Discomfort	19	19
Headache	18	18
Inadequate Osseointegration	16	16
Drug Resistant Bacterial Infection	15	15
Cellulitis	13	13
Purulent Discharge	13	13
Head Injury	13	13
Seroma	11	11
Skin Erosion	11	11
Inflammation	10	10
Patient Problem/Medical Problem	10	10
Ulcer	8	8
Swelling	4	4
No Code Available	3	3
Hemorrhage/Bleeding	3	3
Hearing Impairment	3	3
Post Traumatic Wound Infection	2	2
Fever	2	2
Erosion	2	2
Meningitis	2	2
Skin Disorders	1	1
Ossification	1	1
Erythema	1	1
No Information	1	1
Laceration(s)	1	1
Dizziness	1	1
Nausea	1	1
Hemolysis	1	1
Electric Shock	1	1
No Consequences Or Impact To Patient	1	1