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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
Regulation Description 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

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 54 54
High impedance 10 10
Over-Sensing 10 10
Signal Artifact/Noise 8 8
High Capture Threshold 7 7
Impedance Problem 7 7
Connection Problem 6 6
Fracture 6 6
Insufficient Information 4 4
Ambient Noise Problem 4 4
Low impedance 3 3
Failure to Capture 3 3
Break 3 3
Mechanical Problem 2 2
Capturing Problem 2 2
Electrical /Electronic Property Problem 2 2
Material Integrity Problem 2 2
Material Deformation 1 1
High Sensing Threshold 1 1
Device Markings/Labelling Problem 1 1
Electronic Property Issue 1 1
Intermittent Capture 1 1
Difficult or Delayed Positioning 1 1
Pacing Problem 1 1
Pocket Stimulation 1 1
Patient Lead 1 1
Unstable Capture Threshold 1 1
Device Fell 1 1
Detachment of Device or Device Component 1 1
Device Operates Differently Than Expected 1 1
Human-Device Interface Problem 1 1
Retraction Problem 1 1
Shelf Life Exceeded 1 1
Appropriate Term/Code Not Available 1 1
Noise, Audible 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 46 46
Unspecified Infection 44 44
Erosion 6 6
No Consequences Or Impact To Patient 5 5
Sepsis 4 4
Therapeutic Response, Decreased 4 4
No Information 3 3
Syncope 3 3
Chest Pain 3 3
Death 3 3
Pocket Erosion 2 2
Dizziness 2 2
Wound Dehiscence 2 2
No Clinical Signs, Symptoms or Conditions 2 2
Pericardial Effusion 1 1
Skin Inflammation 1 1
Palpitations 1 1
Dyspnea 1 1
Fever 1 1
Hematoma 1 1
Perforation 1 1
Muscle Stimulation 1 1
No Code Available 1 1
Complaint, Ill-Defined 1 1
Cardiac Perforation 1 1
No Patient Involvement 1 1
Ventricular Fibrillation 1 1
Burning Sensation 1 1
Necrosis 1 1
Undesired Nerve Stimulation 1 1
Head Injury 1 1
Bacterial Infection 1 1
Bradycardia 1 1

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