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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device stimulator, brain, implanted, for behavior modification
Product CodeMFR
Device Class Humanitarian Device Exemption

Device Problems
High impedance 9
No Known Device Problem 7
Device operates differently than expected 6
Break 5
Malposition of device 2
Therapy delivered to incorrect body area 2
Inappropriate shock 2
Low impedance 1
Delayed charge time 1
Migration of device or device component 1
Electromagnetic compatibility issue 1
Material deformation 1
Total Device Problems 38

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