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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device cable, electrode
Regulation Description Electrode cable.
Product CodeIKD
Regulation Number 890.1175
Device Class 2

MDR Year MDR Reports MDR Events
2021 12 12
2022 17 17
2023 7 9
2024 10 10
2025 43 43

Device Problems MDRs with this Device Problem Events in those MDRs
Biocompatibility 29 29
Incorrect, Inadequate or Imprecise Result or Readings 15 15
Connection Problem 6 6
Overheating of Device 5 5
Adverse Event Without Identified Device or Use Problem 4 4
Mechanical Problem 3 3
Device Contaminated During Manufacture or Shipping 2 2
Communication or Transmission Problem 2 3
Thermal Decomposition of Device 2 2
Disconnection 1 1
Break 1 1
Fire 1 1
Image Display Error/Artifact 1 1
Insufficient Information 1 1
Failure to Sense 1 2
High Readings 1 1
Use of Device Problem 1 1
Gas/Air Leak 1 1
Misassembled 1 1
Delivered as Unsterile Product 1 1
Optical Problem 1 1
Packaging Problem 1 1
Labelling, Instructions for Use or Training Problem 1 1
Product Quality Problem 1 1
Telemetry Discrepancy 1 1
Low Readings 1 1
Detachment of Device or Device Component 1 1
Device Sensing Problem 1 1
Failure to Advance 1 1
Melted 1 1
Device Displays Incorrect Message 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 49 50
Skin Inflammation/ Irritation 28 28
Insufficient Information 5 5
Unspecified Infection 2 2
Fluid Discharge 2 2
Arrhythmia 1 2
Blister 1 1
Limb Fracture 1 1
Hypoxia 1 1
Hemorrhage/Bleeding 1 1
Heart Block 1 1
Skin Burning Sensation 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Ad-Tech Medical Instrument Corporation II Sep-20-2021
2 Stryker Sustainability Solutions II Aug-20-2024
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