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TPLC
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Device
pacemaker lead adaptor
Product Code
DTD
Regulation Number
870.3620
Device Class
2
Premarket Reviews
Manufacturer
Decision
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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