• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search Back To Search Results
Device stimulator, brain, implanted, for behavior modification
Product CodeMFR
Device Class Humanitarian Device Exemption

Device Problems
No Known Device Problem 23
Device operates differently than expected 14
High impedance 12
Device displays error message 6
Break 5
Low battery 4
Failure to deliver energy 3
Malposition of device 2
Charging issue 2
Therapy delivered to incorrect body area 2
Inappropriate shock 2
Improper or incorrect procedure or method 1
Low impedance 1
Migration of device or device component 1
No device output 1
Difficult to Program or Calibrate 1
Connection issue 1
Battery issue 1
Delayed charge time 1
Incorrect display 1
Electro-magnetic interference (EMI) 1
Noise, Audible 1
Electromagnetic compatibility issue 1
Material deformation 1
Material integrity issue 1
Total Device Problems 89

-
-