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TPLC
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show TPLC since
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Device
defibrillator, implantable, dual-chamber
Product Code
MRM
Device Class
3
Premarket Approvals (PMA)
2019
2020
2021
2022
2023
2024
20
23
18
9
20
0
MDR Year
MDR Reports
MDR Events
2019
345
345
2020
316
316
2021
575
575
2022
505
505
2023
557
557
2024
88
88
Device Problems
MDRs with this Device Problem
Events in those MDRs
Premature Elective Replacement Indicator
864
864
Adverse Event Without Identified Device or Use Problem
408
408
Premature End-of-Life Indicator
315
315
Over-Sensing
147
147
Battery Problem
113
113
Failure to Interrogate
108
108
Inappropriate/Inadequate Shock/Stimulation
93
93
High impedance
54
54
Premature Discharge of Battery
42
42
Display or Visual Feedback Problem
37
37
Low impedance
29
29
Communication or Transmission Problem
24
24
Insufficient Information
22
22
Data Problem
18
18
Device Displays Incorrect Message
16
16
Failure to Deliver Shock/Stimulation
15
15
Interrogation Problem
14
14
Inappropriate or Unexpected Reset
14
14
Application Program Freezes, Becomes Nonfunctional
13
13
Pacemaker Found in Back-Up Mode
9
9
Ambient Noise Problem
9
9
Device Sensing Problem
8
8
Migration or Expulsion of Device
8
8
Incorrect, Inadequate or Imprecise Result or Readings
8
8
No Pacing
8
8
Impedance Problem
8
8
Appropriate Term/Code Not Available
8
8
High Capture Threshold
7
7
Nonstandard Device
7
7
Fracture
7
7
Failure to Capture
7
7
Computer Software Problem
7
7
Connection Problem
7
7
Unexpected Therapeutic Results
7
7
Defective Component
6
6
Loss of Data
6
6
Delayed Charge Time
6
6
Signal Artifact/Noise
6
6
Electromagnetic Interference
6
6
Pacing Problem
5
5
Under-Sensing
5
5
Program or Algorithm Execution Problem
5
5
Device Markings/Labelling Problem
5
5
Defibrillation/Stimulation Problem
5
5
Installation-Related Problem
4
4
Packaging Problem
4
4
Unexpected Shutdown
4
4
Wireless Communication Problem
4
4
Inaccurate Information
4
4
Failure to Sense
4
4
Mechanical Problem
4
4
Erratic or Intermittent Display
4
4
Electrical /Electronic Property Problem
3
3
Loose or Intermittent Connection
3
3
Failure to Convert Rhythm
3
3
Incorrect Interpretation of Signal
3
3
Failure to Transmit Record
3
3
Defective Device
3
3
Missing Information
3
3
Erratic Results
3
3
Migration
3
3
Therapeutic or Diagnostic Output Failure
3
3
No Apparent Adverse Event
2
2
Output Problem
2
2
Charging Problem
2
2
Patient Data Problem
2
2
Application Program Problem
2
2
Device Dislodged or Dislocated
2
2
Incomplete or Missing Packaging
2
2
Radiofrequency Interference (RFI)
2
2
Telemetry Discrepancy
2
2
Failure to Disconnect
2
2
Pacing Intermittently
2
2
Product Quality Problem
2
2
Misconnection
2
2
Labelling, Instructions for Use or Training Problem
2
2
Difficult to Interrogate
2
2
Image Display Error/Artifact
2
2
Break
2
2
Intermittent Capture
2
2
Failure to Back-Up
1
1
No Display/Image
1
1
Difficult to Insert
1
1
Incorrect Measurement
1
1
Pacing Inadequately
1
1
Unable to Obtain Readings
1
1
Material Rupture
1
1
High Sensing Threshold
1
1
Low Sensing Threshold
1
1
Tear, Rip or Hole in Device Packaging
1
1
Failure to Calibrate
1
1
Decreased Sensitivity
1
1
Shipping Damage or Problem
1
1
Use of Device Problem
1
1
Device Damaged Prior to Use
1
1
Electrical Shorting
1
1
Electromagnetic Compatibility Problem
1
1
Expulsion
1
1
Detachment of Device or Device Component
1
1
Calibration Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
1424
1424
Unspecified Infection
323
323
No Known Impact Or Consequence To Patient
214
214
No Information
146
146
Insufficient Information
63
63
Shock from Patient Lead(s)
37
37
Pocket Erosion
23
23
Death
19
19
No Patient Involvement
17
17
Ventricular Fibrillation
16
16
No Consequences Or Impact To Patient
12
12
Ventricular Tachycardia
11
11
Electric Shock
11
11
Bacterial Infection
9
9
Syncope/Fainting
8
8
Hematoma
8
8
Atrial Fibrillation
8
8
Endocarditis
8
8
Implant Pain
8
8
Tachycardia
8
8
Sepsis
7
7
Discomfort
7
7
Dyspnea
7
7
Cardiac Arrest
6
6
Pain
6
6
Dizziness
5
5
Chest Pain
5
5
Failure of Implant
5
5
Shock
5
5
Arrhythmia
4
4
Pneumothorax
4
4
Pneumonia
3
3
Wound Dehiscence
3
3
Bradycardia
3
3
Asystole
3
3
Anxiety
3
3
Foreign Body In Patient
2
2
Swelling
2
2
Inflammation
2
2
Twiddlers Syndrome
2
2
Perforation
2
2
Fever
2
2
Staphylococcus Aureus
2
2
Distress
2
2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
2
2
Loss of consciousness
2
2
Bruise/Contusion
2
2
Hemorrhage/Bleeding
2
2
Liver Damage/Dysfunction
1
1
Swelling/ Edema
1
1
Tingling
1
1
Liver Failure
1
1
Necrosis
1
1
Hyperbilirubinemia
1
1
Local Reaction
1
1
Skin Inflammation/ Irritation
1
1
Low Blood Pressure/ Hypotension
1
1
Fluid Discharge
1
1
Viral Infection
1
1
Muscle Stimulation
1
1
Blister
1
1
Headache
1
1
Numbness
1
1
Fainting
1
1
Cardiopulmonary Arrest
1
1
Discharge
1
1
Abrasion
1
1
Malaise
1
1
Heart Failure
1
1
No Code Available
1
1
Cellulitis
1
1
Foreign Body Reaction
1
1
Myocarditis
1
1
Diminished Pulse Pressure
1
1
Not Applicable
1
1
Hemothorax
1
1
Burning Sensation
1
1
Impaired Healing
1
1
Heart Failure/Congestive Heart Failure
1
1
Sudden Cardiac Death
1
1
Palpitations
1
1
Fatigue
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
BIOTRONIK Inc
II
Apr-21-2021
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