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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 33 33

Device Problems MDRs with this Device Problem Events in those MDRs
Detachment of Device or Device Component 19 19
Incorrect, Inadequate or Imprecise Result or Readings 16 16
Device Sensing Problem 12 12
Use of Device Problem 8 8
Failure to Sense 7 7
Unable to Obtain Readings 7 7
False Negative Result 6 6
Break 5 5
Inappropriate Audible Prompt/Feedback 5 5
Adverse Event Without Identified Device or Use Problem 4 4
Material Separation 4 4
Material Fragmentation 3 3
Device Unsafe to Use in Environment 2 2
Connection Problem 2 2
False Positive Result 2 2
Flaked 2 2
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
Fracture 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

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 50 50
Foreign Body In Patient 18 18
No Consequences Or Impact To Patient 12 12
No Known Impact Or Consequence To Patient 7 7
Burn(s) 5 5
Nerve Damage 5 5
Device Embedded In Tissue or Plaque 4 4
Discomfort 2 2
No Information 1 1
Inflammation 1 1
Perforation 1 1
Paralysis 1 1
Insufficient Information 1 1
Laceration(s) 1 1
Unspecified Tissue Injury 1 1

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