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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device electrode, needle
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
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 19 19

Device Problems MDRs with this Device Problem Events in those MDRs
Detachment of Device or Device Component 17 17
Device Sensing Problem 12 12
Use of Device Problem 8 8
Failure to Sense 7 7
Unable to Obtain Readings 7 7
Incorrect, Inadequate or Imprecise Result or Readings 7 7
Break 5 5
Inappropriate Audible Prompt/Feedback 5 5
Material Separation 4 4
Adverse Event Without Identified Device or Use Problem 4 4
False Negative Result 3 3
Material Fragmentation 3 3
Flaked 2 2
Device Unsafe to Use in Environment 2 2
Connection Problem 2 2
Appropriate Term/Code Not Available 1 1
Physical Resistance/Sticking 1 1
Intermittent Loss of Power 1 1
Defective Component 1 1
Component Missing 1 1
Incomplete or Missing Packaging 1 1
Defective Device 1 1
Fracture 1 1
Entrapment of Device 1 1
Overheating of Device 1 1
Failure to Analyze Signal 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 39 39
Foreign Body In Patient 16 16
No Consequences Or Impact To Patient 12 12
No Known Impact Or Consequence To Patient 7 7
Burn(s) 5 5
Nerve Damage 4 4
Device Embedded In Tissue or Plaque 4 4
Discomfort 2 2
No Information 1 1
Unspecified Tissue Injury 1 1
Insufficient Information 1 1
Paralysis 1 1
Perforation 1 1
Inflammation 1 1
Laceration(s) 1 1

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