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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device pacemaker, cardiac, external transcutaneous (non-invasive)
Regulation Description External transcutaneous cardiac pacemaker (noninvasive).
Product CodeDRO
Regulation Number 870.5550
Device Class 2

MDR Year MDR Reports MDR Events
2020 19 19
2021 22 22
2023 6 6
2024 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Peeled/Delaminated 9 9
Material Separation 7 7
Sparking 4 4
Arcing 4 4
Device Emits Odor 3 3
Defibrillation/Stimulation Problem 2 2
No Pacing 2 2
Failure to Deliver Shock/Stimulation 2 2
Leak/Splash 1 1
Fire 1 1
Device Alarm System 1 1
Insufficient Information 1 1
Failure to Sense 1 1
Therapeutic or Diagnostic Output Failure 1 1
Inability to Auto-Fill 1 1
Battery Problem 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Failure to Capture 1 1
Device Sensing Problem 1 1
No Apparent Adverse Event 1 1
Fracture 1 1
Device Dislodged or Dislocated 1 1
Protective Measures Problem 1 1
Appropriate Term/Code Not Available 1 1
Overheating of Device 1 1
Failure to Analyze Signal 1 1
Electrical /Electronic Property Problem 1 1
Output below Specifications 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 18 18
No Consequences Or Impact To Patient 9 9
Insufficient Information 6 6
Superficial (First Degree) Burn 3 3
No Known Impact Or Consequence To Patient 3 3
Burn(s) 3 3
No Patient Involvement 3 3
Burn, Thermal 2 2
Skin Irritation 1 1
No Information 1 1
Erythema 1 1
Bradycardia 1 1
Asystole 1 1
Partial thickness (Second Degree) Burn 1 1
Full thickness (Third Degree) Burn 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Smiths Medical ASD Inc. II Oct-13-2021
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