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TPLC
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show TPLC since
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Device
pacemaker, cardiac, external transcutaneous (non-invasive)
Product Code
DRO
Regulation Number
870.5550
Device Class
2
MDR Year
MDR Reports
MDR Events
2014
2
2
2015
41
41
2016
49
49
2017
15
15
2018
64
64
2019
93
93
2020
19
19
2021
22
22
2023
6
6
2024
2
2
Device Problems
MDRs with this Device Problem
Events in those MDRs
Pacing Problem
111
111
Device Displays Incorrect Message
35
35
Device Operates Differently Than Expected
17
17
Failure of Device to Self-Test
15
15
Gel Leak
14
14
Material Separation
13
13
Output Problem
11
11
Peeled/Delaminated
10
10
Sparking
7
7
Defibrillation/Stimulation Problem
5
5
Electrical /Electronic Property Problem
5
5
Failure to Capture
5
5
Detachment of Device or Device Component
5
5
Device Emits Odor
4
4
Arcing
4
4
Connection Problem
4
4
Delamination
4
4
Device Sensing Problem
3
3
Appropriate Term/Code Not Available
3
3
No Pacing
3
3
Loss of or Failure to Bond
3
3
Failure to Charge
2
2
Inappropriate/Inadequate Shock/Stimulation
2
2
Unable to Obtain Readings
2
2
Noise, Audible
2
2
Unexpected Shutdown
2
2
Inappropriate or Unexpected Reset
2
2
Failure to Deliver Shock/Stimulation
2
2
Communication or Transmission Problem
2
2
Arcing of Electrodes
2
2
Failure to Align
1
1
Low Battery
1
1
Battery Problem
1
1
Capturing Problem
1
1
Device Dislodged or Dislocated
1
1
Electrical Shorting
1
1
Material Integrity Problem
1
1
Adverse Event Without Identified Device or Use Problem
1
1
Output below Specifications
1
1
Programming Issue
1
1
Protective Measures Problem
1
1
Therapeutic or Diagnostic Output Failure
1
1
No Apparent Adverse Event
1
1
Insufficient Information
1
1
Incomplete or Inadequate Connection
1
1
Activation Problem
1
1
Improper Device Output
1
1
Inadequate User Interface
1
1
Firing Problem
1
1
Failure to Analyze Signal
1
1
Self-Activation or Keying
1
1
Failure to Sense
1
1
Smoking
1
1
Inaccurate Synchronization
1
1
Improper or Incorrect Procedure or Method
1
1
Energy Output Problem
1
1
Output above Specifications
1
1
Overheating of Device
1
1
Failure to Power Up
1
1
Product Quality Problem
1
1
Pacing Intermittently
1
1
Intermittent Continuity
1
1
Use of Incorrect Control/Treatment Settings
1
1
Device Alarm System
1
1
Low Audible Alarm
1
1
Alarm Not Visible
1
1
Failure To Adhere Or Bond
1
1
Signal Artifact/Noise
1
1
Break
1
1
Loose or Intermittent Connection
1
1
Fire
1
1
Fracture
1
1
Material Fragmentation
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Patient Involvement
154
154
No Known Impact Or Consequence To Patient
45
45
No Consequences Or Impact To Patient
42
42
No Information
27
27
No Clinical Signs, Symptoms or Conditions
17
17
Burn(s)
7
7
Insufficient Information
6
6
Death
5
5
Burn, Thermal
3
3
Superficial (First Degree) Burn
3
3
Bradycardia
2
2
Skin Irritation
2
2
Partial thickness (Second Degree) Burn
2
2
Full thickness (Third Degree) Burn
1
1
Shock from Patient Lead(s)
1
1
No Code Available
1
1
Lymphoma
1
1
Asystole
1
1
Erythema
1
1
Weight Changes
1
1
Injury
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Covidien LLC
II
Sep-02-2015
2
Covidien LLC
I
Oct-15-2014
3
Covidien LLC
II
Apr-29-2013
4
Smiths Medical ASD Inc.
II
Oct-13-2021
5
TZ Medical Inc.
II
May-30-2013
6
Welch Allyn Protocol, Inc
II
Jan-24-2011
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