TPLC - Total Product Life Cycle

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Device	neurosurgical nerve locator
Regulation Description	Surgical nerve stimulator/locator.
Definition	To locate or monitor function of spinal nerve roots or peripheral nerves during neurosurgery.
Product Code	PDQ
Regulation Number	874.1820
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings	10	10
Break	6	6
Fracture	5	5
Device Alarm System	4	4
Adverse Event Without Identified Device or Use Problem	4	4
Failure to Deliver Shock/Stimulation	4	4
Communication or Transmission Problem	2	2
Crack	2	2
Patient-Device Incompatibility	2	2
Inappropriate/Inadequate Shock/Stimulation	2	2
Display or Visual Feedback Problem	2	2
Signal Artifact/Noise	1	1
Circuit Failure	1	1
Entrapment of Device	1	1
False Negative Result	1	1
Device Damaged Prior to Use	1	1
Insufficient Information	1	1
Erratic Results	1	1
No Audible Alarm	1	1
Difficult to Remove	1	1
Patient Device Interaction Problem	1	1
Use of Device Problem	1	1
Audible Prompt/Feedback Problem	1	1
Computer Operating System Problem	1	1
Detachment of Device or Device Component	1	1
Power Problem	1	1
Electromagnetic Interference	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	24	24
Insufficient Information	5	5
No Consequences Or Impact To Patient	4	4
Foreign Body In Patient	3	3
Paralysis	2	2
Nerve Damage	2	2
Device Embedded In Tissue or Plaque	2	2
Edema	1	1
No Known Impact Or Consequence To Patient	1	1
Muscle Spasm(s)	1	1
Numbness	1	1
Awareness during Anaesthesia	1	1
Pain	1	1
Anaphylactic Shock	1	1
Convulsion/Seizure	1	1
Dysgeusia	1	1
Spinal Cord Injury	1	1
Nervous System Injury	1	1
Full thickness (Third Degree) Burn	1	1