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

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	1283	1284
Migration	108	108
Fracture	85	85
Break	56	56
Insufficient Information	54	54
Therapeutic or Diagnostic Output Failure	47	48
Use of Device Problem	21	21
High impedance	19	19
Material Fragmentation	17	17
Intermittent Communication Failure	16	16
Inappropriate/Inadequate Shock/Stimulation	14	15
Improper or Incorrect Procedure or Method	13	13
Migration or Expulsion of Device	13	13
Appropriate Term/Code Not Available	13	13
Patient-Device Incompatibility	11	11
Impedance Problem	11	11
Malposition of Device	8	8
Disconnection	6	6
Patient Device Interaction Problem	6	9
No Apparent Adverse Event	5	5
Positioning Problem	5	5
Difficult to Insert	5	5
Overheating of Device	4	4
Unintended Electrical Shock	4	4
Shipping Damage or Problem	4	4
Battery Problem	4	4
Mechanical Problem	3	3
Difficult to Remove	3	3
Component Missing	3	3
Material Twisted/Bent	3	3
Device Unsafe to Use in Environment	3	3
Temperature Problem	2	2
Therapy Delivered to Incorrect Body Area	2	2
Loss of Power	2	2
Human-Device Interface Problem	2	2
Device Dislodged or Dislocated	2	2
Failure to Advance	2	2
Material Protrusion/Extrusion	2	2
Electrical Shorting	2	2
Detachment of Device or Device Component	2	2
Material Erosion	2	2
Output Problem	2	2
Circuit Failure	2	2
Improper Flow or Infusion	1	1
Charging Problem	1	1
Device Difficult to Setup or Prepare	1	1
Difficult or Delayed Positioning	1	1
Electromagnetic Compatibility Problem	1	1
Defective Device	1	1
Expiration Date Error	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Post Operative Wound Infection	451	451
Unspecified Infection	340	340
Inadequate Pain Relief	253	253
Implant Pain	224	224
No Clinical Signs, Symptoms or Conditions	124	125
Pain	107	108
Fluid Discharge	64	64
Erosion	60	60
Wound Dehiscence	43	43
Discomfort	39	39
Failure of Implant	34	34
Electric Shock	33	34
Swelling/ Edema	30	30
Skin Inflammation/ Irritation	29	32
No Consequences Or Impact To Patient	25	25
Insufficient Information	25	25
Skin Erosion	22	22
No Known Impact Or Consequence To Patient	22	22
Fever	19	19
Purulent Discharge	19	19
Burning Sensation	17	17
Bacterial Infection	13	13
Undesired Nerve Stimulation	12	12
Hypersensitivity/Allergic reaction	12	12
Impaired Healing	11	11
Sepsis	11	11
Skin Irritation	11	11
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	10	10
Numbness	9	9
Seroma	9	9
Device Overstimulation of Tissue	8	8
Erythema	8	11
Device Embedded In Tissue or Plaque	7	7
Headache	7	7
Rash	7	10
Skin Infection	6	6
Inflammation	5	5
Ambulation Difficulties	5	5
Hematoma	5	5
Fall	5	5
Shock from Patient Lead(s)	5	5
Chills	5	5
Shaking/Tremors	4	4
Cramp(s) /Muscle Spasm(s)	4	4
Abscess	4	4
Foreign Body In Patient	4	4
Paralysis	4	5
Needle Stick/Puncture	4	4
Cerebrospinal Fluid Leakage	3	3
Itching Sensation	3	3