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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device pacemaker lead adaptor
Product CodeDTD
Regulation Number 870.3620
Device Class 2


Premarket Reviews
ManufacturerDecision
MEDTRONIC INC.
  SUBSTANTIALLY EQUIVALENT 1
OSCOR INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 21 21
2015 41 41
2016 20 20
2017 15 15
2018 29 29
2019 34 34
2020 19 19
2021 23 23
2022 25 25
2023 28 28
2024 21 21

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 109 109
High impedance 24 24
Over-Sensing 19 19
Signal Artifact/Noise 18 18
Material Integrity Problem 18 18
High Capture Threshold 18 18
Failure to Capture 17 17
Connection Problem 10 10
Impedance Problem 10 10
Low impedance 10 10
Ambient Noise Problem 9 9
Fracture 9 9
Break 7 7
Insufficient Information 6 6
Device Sensing Problem 5 5
Mechanical Problem 5 5
Device Dislodged or Dislocated 5 5
Capturing Problem 5 5
Pacing Problem 4 4
Device Operates Differently Than Expected 4 4
Use of Device Problem 3 3
Pocket Stimulation 3 3
Under-Sensing 3 3
Material Separation 2 2
Detachment of Device or Device Component 2 2
Human-Device Interface Problem 2 2
Off-Label Use 2 2
High Sensing Threshold 2 2
Noise, Audible 2 2
Shelf Life Exceeded 2 2
Degraded 2 2
Appropriate Term/Code Not Available 2 2
Electrical /Electronic Property Problem 2 2
Retraction Problem 1 1
Difficult To Position 1 1
No Apparent Adverse Event 1 1
Mechanical Jam 1 1
Loose or Intermittent Connection 1 1
Premature Discharge of Battery 1 1
Electronic Property Issue 1 1
Battery Problem 1 1
Intermittent Capture 1 1
Component(s), broken 1 1
Unstable Capture Threshold 1 1
Difficult or Delayed Positioning 1 1
Material Deformation 1 1
Failure to Sense 1 1
Therapeutic or Diagnostic Output Failure 1 1
Device Fell 1 1
Device Markings/Labelling Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Unspecified Infection 85 85
No Known Impact Or Consequence To Patient 64 64
No Clinical Signs, Symptoms or Conditions 41 41
No Consequences Or Impact To Patient 25 25
Sepsis 7 7
Insufficient Information 7 7
Erosion 6 6
Death 5 5
Dizziness 5 5
Pocket Erosion 5 5
Therapeutic Response, Decreased 5 5
Syncope 3 3
Hypersensitivity/Allergic reaction 3 3
Failure of Implant 3 3
No Code Available 3 3
No Information 3 3
Hematoma 3 3
Cardiac Perforation 3 3
Chest Pain 3 3
Bradycardia 3 3
Wound Dehiscence 2 2
Arrhythmia 2 2
Therapeutic Response, Increased 2 2
Complaint, Ill-Defined 2 2
Muscle Stimulation 2 2
Perforation 2 2
Pericardial Effusion 2 2
Fever 2 2
Seroma 2 2
Endocarditis 2 2
Undesired Nerve Stimulation 2 2
Discomfort 2 2
Fluid Discharge 2 2
Pain 2 2
Device Embedded In Tissue or Plaque 1 1
Respiratory Failure 1 1
Heart Block 1 1
Bacterial Infection 1 1
Heart Failure/Congestive Heart Failure 1 1
Congenital Defect/Deformity 1 1
Dyspnea 1 1
No Patient Involvement 1 1
Skin Inflammation 1 1
Septic Shock 1 1
Chills 1 1
Burning Sensation 1 1
Ventricular Fibrillation 1 1
Skin Erosion 1 1
Palpitations 1 1
Cardiac Tamponade 1 1

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