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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device recorder, event, implantable cardiac, (with arrhythmia detection)
Regulation Description Arrhythmia detector and alarm (including ST-segment measurement and alarm).
Product CodeMXD
Regulation Number 870.1025
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT
  SUBSTANTIALLY EQUIVALENT 1
ABBOTT MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
BIOTRONIK, INC.
  SUBSTANTIALLY EQUIVALENT 3
BOSTON SCIENTIFIC CORP
  SUBSTANTIALLY EQUIVALENT 1
BOSTON SCIENTIFIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 9

MDR Year MDR Reports MDR Events
2021 694 694
2022 1362 1369
2023 1766 1769
2024 3019 3020
2025 3415 3415
2026 1803 1803

Device Problems MDRs with this Device Problem Events in those MDRs
Reset Problem 2341 2342
Premature Discharge of Battery 1800 1801
Output Problem 1243 1243
Inappropriate or Unexpected Reset 1216 1216
Adverse Event Without Identified Device or Use Problem 1097 1098
Signal Artifact/Noise 1067 1067
Under-Sensing 951 952
Over-Sensing 747 747
Data Problem 664 664
Device Sensing Problem 650 651
Migration or Expulsion of Device 564 564
Communication or Transmission Problem 378 380
Battery Problem 324 324
Electromagnetic Interference 236 236
Failure to Interrogate 195 196
Unable to Obtain Readings 178 178
Mechanical Problem 121 121
Appropriate Device Problem Term/Code Not Available 104 104
Premature Elective Replacement Indicator 78 78
Decreased Sensitivity 71 71
Ambient Noise Problem 67 67
Migration 66 66
Failure to Sense 54 54
False Positive Result 52 52
Failure to Read Input Signal 34 34
Program or Algorithm Execution Problem 32 32
Device Dislodged or Dislocated 31 31
Device-Device Incompatibility 30 30
Device Displays Incorrect Message 23 23
Incorrect, Inadequate or Imprecise Result or Readings 20 20
Loss of Data 18 18
Insufficient Device Problem Information 16 16
Premature End-of-Life Indicator 15 15
Failure to Transmit Record 14 14
Break 14 14
Expulsion 12 12
Malposition of Device 12 12
Use of Device Problem 9 9
Difficult to Insert 9 9
Difficult to Remove 8 8
Defective Device 8 8
Material Integrity Problem 8 8
Interrogation Problem 8 8
Difficult or Delayed Positioning 7 7
Battery Problem: High Impedance 6 6
Human-Device Interface Problem 6 6
Off-Label Use 6 6
Electrical /Electronic Property Problem 6 6
Positioning Problem 5 5
False Negative Result 5 5

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 10510 10516
Unspecified Infection 431 431
Wound Dehiscence 407 407
Discomfort 219 219
Erosion 185 185
Pain 149 149
Implant Pain 130 130
Pocket Erosion 105 105
Erythema 63 63
Purulent Discharge 39 39
Impaired Healing 38 39
Hypersensitivity/Allergic reaction 37 37
Swelling/ Edema 34 34
Hemorrhage/Blood Loss/Bleeding 30 30
Twiddlers Syndrome 22 22
Insufficient Information 19 22
Skin Inflammation/ Irritation 18 18
Itching Sensation 15 15
Hematoma 15 15
Inflammation 13 13
Rash 13 13
Medical device site infection 12 12
Fluid Discharge 12 12
Chest Pain 10 10
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available 10 10
Failure of Implant 9 10
No Code Available 9 9
Burning Sensation 9 9
Skin Erosion 8 8
Bacterial Infection 7 8
Sepsis 6 6
Fever 5 5
Arrhythmia 5 5
Bruise/Contusion 5 5
Cellulitis 5 5
Dyspnea 4 4
Anxiety 4 4
Foreign Body In Patient 4 4
Cardiac Arrest 3 3
Scar Tissue 3 3
Perforation 3 3
Unspecified Tissue Injury 3 3
Dizziness 3 3
Atrial Fibrillation 3 3
Laceration(s) 2 3
Fall 2 2
Reaction to Medicinal Component of Device 2 2
Abscess 2 2
Bradycardia 2 2
Pneumothorax 2 2

Recalls
Manufacturer Recall Class Date Posted
1 Boston Scientific Corporation II May-01-2026
2 Boston Scientific Corporation II Oct-25-2024
3 Medtronic Inc. II Dec-01-2023
4 Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) II Mar-11-2022
5 Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) II Jul-20-2021
6 Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) II Jul-14-2021
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