TPLC - Total Product Life Cycle

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Device	stimulator, spinal-cord, implanted (pain relief)
Regulation Description	Implanted spinal cord stimulator for pain relief.
Product Code	GZB
Regulation Number	882.5880
Device Class	2

Premarket Reviews
Manufacturer	Decision
BOSTON SCIENTIFIC NEUROMODULATION
	SUBSTANTIALLY EQUIVALENT	3

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	1085	1086
Migration	79	79
Fracture	58	58
Insufficient Device Problem Information	46	46
Break	39	39
Use of Device Problem	21	21
Intermittent Communication Failure	17	17
Material Fragmentation	14	14
Improper or Incorrect Procedure or Method	10	10
Malposition of Device	8	8
Appropriate Device Problem Term/Code Not Available	8	8
Impedance Problem	7	7
Patient-Device Incompatibility	7	7
Therapeutic or Diagnostic Output Failure	5	5
Battery Problem	4	4
No Apparent Adverse Event	4	4
Device Unsafe to Use in Environment	3	3
Migration or Expulsion of Device	3	3
Difficult to Insert	3	3
High impedance	2	2
Incomplete or Inadequate Connection	2	2
Material Twisted/Bent	2	2
Temperature Problem	2	2
Circuit Failure	2	2
Material Separation	2	2
Human-Device Interface Problem	2	2
Detachment of Device or Device Component	2	2
Patient Device Interaction Problem	2	2
Mechanical Problem	2	2
Device Difficult to Setup or Prepare	1	1
Therapy Delivered to Incorrect Body Area	1	1
Failure to Advance	1	1
Positioning Problem	1	1
Electromagnetic Compatibility Problem	1	1
Off-Label Use	1	1
Connection Problem	1	1
Overheating of Device	1	1
Difficult or Delayed Positioning	1	1
Device Contaminated During Manufacture or Shipping	1	2
Loose or Intermittent Connection	1	1
Mechanical Jam	1	1
Unintended Movement	1	1
Expulsion	1	1
Unintended Collision	1	1
Material Protrusion/Extrusion	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Post Operative Wound Infection	426	426
Unspecified Infection	267	267
Implant Pain	258	258
Inadequate Pain Relief	175	175
No Clinical Signs, Symptoms or Conditions	119	120
Fluid Discharge	65	65
Pain	59	60
Erosion	42	42
Wound Dehiscence	42	42
Failure of Implant	34	34
Swelling/ Edema	30	30
Insufficient Information	27	27
Electric Shock	27	28
Skin Inflammation/ Irritation	26	29
Discomfort	22	22
Fever	19	19
Purulent Discharge	16	16
Burning Sensation	13	13
Hypersensitivity/Allergic reaction	13	13
Skin Erosion	13	13
Impaired Healing	12	12
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	10	10
Numbness	8	8
Erythema	8	11
Bacterial Infection	7	7
Headache	7	7
Skin Infection	6	6
Rash	6	9
Sepsis	6	6
Device Embedded In Tissue or Plaque	6	6
Chills	5	5
Fall	5	5
Inflammation	5	5
Seroma	5	5
Cramp(s) /Muscle Spasm(s)	4	4
Abscess	4	4
Device Overstimulation of Tissue	4	4
Needle Stick/Puncture	4	4
Ambulation or Postural Difficulties	4	4
Undesired Nerve Stimulation	4	4
Drug Resistant Bacterial Infection	3	3
Hematoma	3	3
Foreign Body In Patient	3	3
Shock from Patient Lead(s)	3	3
Itching Sensation	3	3
Cerebrospinal Fluid Leakage	3	3
Shaking/Tremors	3	3
Memory Loss/Impairment	3	3
Paresthesia	2	2
Hemorrhage/Blood Loss/Bleeding	2	2