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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 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 90 90
Over-Sensing 16 16
High impedance 14 14
Signal Artifact/Noise 12 12
High Capture Threshold 12 12
Ambient Noise Problem 9 9
Connection Problem 8 8
Impedance Problem 8 8
Failure to Capture 7 7
Break 6 6
Fracture 6 6
Low impedance 6 6
Insufficient Information 4 4
Capturing Problem 3 3
Use of Device Problem 3 3
Device Sensing Problem 3 3
Detachment of Device or Device Component 2 2
Under-Sensing 2 2
High Sensing Threshold 2 2
Mechanical Problem 2 2
Electrical /Electronic Property Problem 2 2
Pacing Problem 2 2
Pocket Stimulation 2 2
Off-Label Use 2 2
Noise, Audible 2 2
Material Integrity Problem 2 2
Mechanical Jam 1 1
Material Deformation 1 1
Appropriate Term/Code Not Available 1 1
Therapeutic or Diagnostic Output Failure 1 1
No Apparent Adverse Event 1 1
Device Fell 1 1
Unstable Capture Threshold 1 1
Retraction Problem 1 1
Failure to Sense 1 1
Material Separation 1 1
Shelf Life Exceeded 1 1
Device Alarm System 1 1
Difficult or Delayed Positioning 1 1
Intermittent Capture 1 1
Premature Discharge of Battery 1 1
Loose or Intermittent Connection 1 1
Device Markings/Labelling Problem 1 1
Device Operates Differently Than Expected 1 1
Electronic Property Issue 1 1
Human-Device Interface Problem 1 1
Battery Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Unspecified Infection 73 73
No Known Impact Or Consequence To Patient 46 46
No Clinical Signs, Symptoms or Conditions 34 34
Insufficient Information 7 7
Erosion 6 6
Sepsis 6 6
No Consequences Or Impact To Patient 5 5
Pocket Erosion 4 4
Therapeutic Response, Decreased 4 4
Failure of Implant 3 3
Chest Pain 3 3
Death 3 3
Syncope 3 3
No Information 3 3
Pericardial Effusion 2 2
Wound Dehiscence 2 2
Endocarditis 2 2
Cardiac Perforation 2 2
Dizziness 2 2
Fluid Discharge 2 2
No Patient Involvement 1 1
Complaint, Ill-Defined 1 1
Skin Inflammation 1 1
Palpitations 1 1
Respiratory Failure 1 1
Cardiac Tamponade 1 1
Skin Erosion 1 1
Ventricular Fibrillation 1 1
Burning Sensation 1 1
Fever 1 1
Head Injury 1 1
Hematoma 1 1
Necrosis 1 1
Undesired Nerve Stimulation 1 1
Perforation 1 1
Muscle Stimulation 1 1
Arrhythmia 1 1
Bacterial Infection 1 1
Dyspnea 1 1
Bradycardia 1 1
Heart Block 1 1
Heart Failure/Congestive Heart Failure 1 1
No Code Available 1 1
Device Embedded In Tissue or Plaque 1 1

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