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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device stimulator, intracerebral/subcortical, implanted
Definition Call for PMAs to be filed by 3/1/89 per 53 FR 43621 on 12/1/88
Product CodeGYZ
Regulation Number 882.5840
Device Class 3

MDR Year MDR Reports MDR Events
2014 2 2
2016 1 1
2023 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Failure To Adhere Or Bond 1 1
Contamination 1 1
Fracture 1 1
High impedance 1 1
Ambient Noise Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Bacterial Infection 1 1
Purulent Discharge 1 1
Hemorrhage/Bleeding 1 1
Neurological Deficit/Dysfunction 1 1
Impaired Healing 1 1
No Patient Involvement 1 1
No Clinical Signs, Symptoms or Conditions 1 1

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