TPLC - Total Product Life Cycle

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Device	shunt, central nervous system and components
Regulation Description	Central nervous system fluid shunt and components.
Product Code	JXG
Regulation Number	882.5550
Device Class	2

Premarket Reviews
Manufacturer	Decision
AESCULAP, INC.
	SUBSTANTIALLY EQUIVALENT	1
ANUNCIA MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	2
BORVO MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
BRAINSPACE, INC.
	SUBSTANTIALLY EQUIVALENT	1
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
	SUBSTANTIALLY EQUIVALENT	6
IRRAS USA
	SUBSTANTIALLY EQUIVALENT	1
IRRAS USA, INC.
	SUBSTANTIALLY EQUIVALENT	1
JMED(SHENZHEN) TECHNOLOGY LIMITED
	SUBSTANTIALLY EQUIVALENT	1
MEDTRONIC NEUROSURGERY
	SUBSTANTIALLY EQUIVALENT	2
PHASOR HEALTH, LLC
	SUBSTANTIALLY EQUIVALENT	1
	SUBSTANTIALLY EQUIVALENT - WITH DRUG	1
SOPHYSA
	SUBSTANTIALLY EQUIVALENT	3

Device Problems	MDRs with this Device Problem	Events in those MDRs
Infusion or Flow Problem	2042	2042
Mechanical Problem	900	900
Obstruction of Flow	746	748
Insufficient Information	638	638
Break	631	631
Adverse Event Without Identified Device or Use Problem	372	373
Fluid/Blood Leak	341	342
Physical Resistance/Sticking	296	296
Fracture	281	282
Complete Blockage	262	262
Mechanics Altered	136	136
Output Problem	101	103
Leak/Splash	95	95
Pressure Problem	91	91
Crack	89	89
Device Difficult to Program or Calibrate	81	81
Disconnection	72	72
Mechanical Jam	68	68
Migration	66	66
No Flow	53	53
Material Split, Cut or Torn	47	47
Appropriate Term/Code Not Available	41	41
Device Dislodged or Dislocated	36	39
Excess Flow or Over-Infusion	35	35
Product Quality Problem	34	34
Insufficient Flow or Under Infusion	32	32
Incorrect, Inadequate or Imprecise Result or Readings	31	31
Material Integrity Problem	28	28
Improper Flow or Infusion	27	27
Connection Problem	26	26
Detachment of Device or Device Component	24	24
Failure to Align	24	24
Use of Device Problem	24	24
Material Separation	20	20
Microbial Contamination of Device	19	19
Separation Problem	16	16
Material Fragmentation	16	16
Loose or Intermittent Connection	15	16
No Device Output	15	15
Positioning Problem	14	14
Entrapment of Device	13	13
Material Twisted/Bent	13	13
Patient Device Interaction Problem	12	12
Material Frayed	12	12
Material Puncture/Hole	12	12
Inappropriate or Unexpected Reset	11	11
Migration or Expulsion of Device	10	10
Unintended Movement	9	9
Defective Component	9	15
Difficult to Remove	9	9

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Hydrocephalus	2510	2510
No Clinical Signs, Symptoms or Conditions	1702	1703
Insufficient Information	758	758
Headache	289	297
Failure of Implant	225	231
Unspecified Infection	186	187
Cerebral Ventriculomeglia	174	174
Cerebrospinal Fluid Leakage	135	143
Unspecified Tissue Injury	129	129
Vomiting	101	101
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	81	89
Bacterial Infection	77	77
Ambulation Difficulties	73	73
Intracranial Hemorrhage	72	72
Hematoma	69	69
Foreign Body In Patient	63	63
Convulsion/Seizure	61	61
Injury	58	58
Dizziness	53	53
Nausea	48	50
Fever	48	48
Hemorrhage/Bleeding	45	45
Pain	44	46
Confusion/ Disorientation	44	44
Swelling/ Edema	41	41
Cognitive Changes	40	40
Visual Impairment	33	33
Meningitis	28	28
Fatigue	26	26
Abdominal Pain	22	22
Loss of consciousness	21	21
Lethargy	20	20
Coma	20	20
Device Embedded In Tissue or Plaque	20	21
No Known Impact Or Consequence To Patient	20	20
Memory Loss/Impairment	17	17
Brain Injury	16	16
Seroma	16	16
Cyst(s)	16	16
Blurred Vision	16	16
Discomfort	15	15
Irritability	14	14
Unspecified Nervous System Problem	14	14
Impaired Healing	13	19
Cerebral Edema	12	12
Inflammation	12	12
Post Operative Wound Infection	12	12
Hearing Impairment	12	12
Muscle Weakness	11	11
Dysphasia	11	11

Recalls
Manufacturer		Recall Class	Date Posted
1	Integra LifeSciences Corp.	II	Jan-17-2025
2	Integra LifeSciences Corp.	II	Jun-12-2024
3	Medtronic Neurosurgery	II	Aug-17-2023
4	Medtronic Neurosurgery	II	Feb-12-2021
5	Medtronic Neurosurgery	II	Jan-15-2021
6	Natus Manufacturing Limited	II	Feb-22-2021
7	Natus Medical Incorporated	II	Jan-04-2024