TPLC - Total Product Life Cycle

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Device	stimulator, nerve, electrical, percutaneous (pens), for pain relief
Definition	Percutaneous electrical nerve stimulator (pens) is a device used for the treatment of pain. Unlike the classified transcutaneous electrical nerve stimulator that apply an electrical current to electrodes on a patient's skin to deliver stimulation, a pens uses electrodes that are placed percutaneously to deliver stimulation,
Product Code	NHI
Regulation Number	882.5890
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	34	34
Fracture	4	4
Improper or Incorrect Procedure or Method	2	2
Difficult to Remove	2	2
Activation, Positioning or Separation Problem	1	1
Patient-Device Incompatibility	1	1
Retraction Problem	1	1
Physical Resistance/Sticking	1	1
Off-Label Use	1	1
Break	1	1
Migration or Expulsion of Device	1	1
Use of Device Problem	1	1
Difficult or Delayed Separation	1	1
Device Operates Differently Than Expected	1	1
Unexpected Therapeutic Results	1	1
Nonstandard Device	1	1
Unraveled Material	1	1
Biocompatibility	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Unspecified Infection	15	15
Skin Inflammation/ Irritation	11	11
Fluid Discharge	10	10
Skin Infection	8	8
Pain	8	8
Swelling/ Edema	6	6
Erythema	6	6
Ambulation Difficulties	5	5
Purulent Discharge	5	5
Inflammation	4	4
Bacterial Infection	4	4
Sepsis	3	3
Cellulitis	3	3
Fever	3	3
Foreign Body In Patient	3	3
Pneumothorax	2	2
Low Blood Pressure/ Hypotension	2	2
Hematoma	2	2
Confusion/ Disorientation	2	2
Convulsion/Seizure	2	2
Burning Sensation	2	2
Nodule	2	2
Numbness	2	2
Device Embedded In Tissue or Plaque	1	1
Respiratory Failure	1	1
Subcutaneous Nodule	1	1
Inadequate Pain Relief	1	1
Hemorrhage/Bleeding	1	1
Partial thickness (Second Degree) Burn	1	1
Bradycardia	1	1
Abscess	1	1
Renal Impairment	1	1
Paresis	1	1
Laceration(s)	1	1
Insufficient Information	1	1
Urinary Retention	1	1
Pleural Effusion	1	1
Exposure to Body Fluids	1	1
Needle Stick/Puncture	1	1
Neck Pain	1	1
Skin Erosion	1	1
Paralysis	1	1
Burn(s)	1	1
Post Operative Wound Infection	1	1
Blister	1	1
Muscle Weakness	1	1
Presyncope	1	1
No Clinical Signs, Symptoms or Conditions	1	1
Shock from Patient Lead(s)	1	1
Emotional Changes	1	1