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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

MDR Year MDR Reports MDR Events
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 97 97
Over-Sensing 17 17
High impedance 16 16
High Capture Threshold 15 15
Signal Artifact/Noise 14 14
Failure to Capture 9 9
Ambient Noise Problem 9 9
Connection Problem 8 8
Impedance Problem 8 8
Break 6 6
Insufficient Information 6 6
Low impedance 6 6
Fracture 6 6
Device Sensing Problem 4 4
Capturing Problem 3 3
Pacing Problem 3 3
Use of Device Problem 3 3
Noise, Audible 2 2
Electrical /Electronic Property Problem 2 2
High Sensing Threshold 2 2
Pocket Stimulation 2 2
Under-Sensing 2 2
Detachment of Device or Device Component 2 2
Material Integrity Problem 2 2
Off-Label Use 2 2
Mechanical Problem 2 2
Material Separation 1 1
Retraction Problem 1 1
Unstable Capture Threshold 1 1
Material Deformation 1 1
No Apparent Adverse Event 1 1
Difficult or Delayed Positioning 1 1
Battery Problem 1 1
Shelf Life Exceeded 1 1
Intermittent Capture 1 1
Therapeutic or Diagnostic Output Failure 1 1
Device Operates Differently Than Expected 1 1
Appropriate Term/Code Not Available 1 1
Failure to Sense 1 1
Human-Device Interface Problem 1 1
Device Fell 1 1
Premature Discharge of Battery 1 1
Device Markings/Labelling Problem 1 1
Loose or Intermittent Connection 1 1
Device Alarm System 1 1
Electronic Property Issue 1 1
Mechanical Jam 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Unspecified Infection 79 79
No Known Impact Or Consequence To Patient 46 46
No Clinical Signs, Symptoms or Conditions 41 41
Insufficient Information 7 7
Sepsis 6 6
Erosion 6 6
Pocket Erosion 5 5
No Consequences Or Impact To Patient 5 5
Dizziness 4 4
Therapeutic Response, Decreased 4 4
Syncope 3 3
Death 3 3
Failure of Implant 3 3
No Information 3 3
Bradycardia 3 3
Chest Pain 3 3
Wound Dehiscence 2 2
Arrhythmia 2 2
Pericardial Effusion 2 2
Endocarditis 2 2
Fever 2 2
Fluid Discharge 2 2
Cardiac Perforation 2 2
Device Embedded In Tissue or Plaque 1 1
Respiratory Failure 1 1
Heart Block 1 1
Bacterial Infection 1 1
Undesired Nerve Stimulation 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
Discomfort 1 1
Chills 1 1
Burning Sensation 1 1
Ventricular Fibrillation 1 1
Skin Erosion 1 1
Palpitations 1 1
Cardiac Tamponade 1 1
Perforation 1 1
Hematoma 1 1
Head Injury 1 1
Muscle Stimulation 1 1
Necrosis 1 1
No Code Available 1 1
Complaint, Ill-Defined 1 1
Hypersensitivity/Allergic reaction 1 1

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