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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device electrode, needle
Regulation Description Needle electrode.
Product CodeGXZ
Regulation Number 882.1350
Device Class 2


Premarket Reviews
ManufacturerDecision
RHYTHMLINK INTERNATIONAL, LLC
  SUBSTANTIALLY EQUIVALENT 2
SPES MEDICA S.R.L.
  SUBSTANTIALLY EQUIVALENT 1
SUZHOU HAISHEN MEDICAL DEVICE ASSOCIATES CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
TECHNOMED EUROPE
  SUBSTANTIALLY EQUIVALENT 1
TEDAN SURGICAL INNOVATIONS INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 14 14
2020 7 7
2021 9 9
2022 18 18
2023 21 21
2024 58 58
2025 48 48

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings 48 48
False Negative Result 36 36
Detachment of Device or Device Component 26 26
Device Sensing Problem 13 13
Use of Device Problem 11 11
Inappropriate Audible Prompt/Feedback 11 11
Break 7 7
Failure to Sense 7 7
Unable to Obtain Readings 7 7
False Positive Result 5 5
Adverse Event Without Identified Device or Use Problem 4 4
Material Separation 4 4
Material Fragmentation 3 3
Connection Problem 3 3
Device Unsafe to Use in Environment 2 2
Product Quality Problem 2 2
Fracture 2 2
Difficult to Open or Close 2 2
Flaked 2 2
Device Slipped 1 1
Entrapment of Device 1 1
Incomplete or Missing Packaging 1 1
Physical Resistance/Sticking 1 1
Defective Component 1 1
Defective Device 1 1
Component Missing 1 1
Defibrillation/Stimulation Problem 1 1
Appropriate Term/Code Not Available 1 1
Overheating of Device 1 1
Failure to Analyze Signal 1 1
Intermittent Loss of Power 1 1
No Device Output 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 108 108
Foreign Body In Patient 25 25
No Consequences Or Impact To Patient 12 12
No Known Impact Or Consequence To Patient 7 7
Nerve Damage 7 7
Burn(s) 6 6
Device Embedded In Tissue or Plaque 4 4
Paralysis 2 2
Needle Stick/Puncture 2 2
Discomfort 2 2
No Information 1 1
Perforation 1 1
Inflammation 1 1
Insufficient Information 1 1
Laceration(s) 1 1
Paresis 1 1
Unspecified Tissue Injury 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Technomed Europe II Jan-07-2022
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