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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device pulse-generator, single chamber, single
Product CodeLWW
Device Class 3

Premarket Approvals (PMA)
2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024
0 0 0 2 0 0 0 0 0 0 0 0 0 0 0 0

MDR Year MDR Reports MDR Events
2017 2 2
2018 1 1
2019 3 3
2020 2 2
2021 2 2
2022 2 2
2023 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Premature Discharge of Battery 4 4
Over-Sensing 3 3
Device Displays Incorrect Message 2 2
Device Sensing Problem 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Data Problem 1 1
Pacing Problem 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Defective Device 1 1
High impedance 1 1
Signal Artifact/Noise 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 4 4
No Consequences Or Impact To Patient 3 3
No Known Impact Or Consequence To Patient 2 2
Syncope 2 2
Bradycardia 2 2
Death 1 1
Dyspnea 1 1
Fatigue 1 1
Unspecified Infection 1 1
Discomfort 1 1

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