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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device implantable radio frequency transponder system
Definition An implantable microtransponder system intended to facilitate access to identification and health information in humans. It is described as consisting of a small implantable electronic microtransponder, an insertion device (introducer), and an electronic scanner (pocket reader). The microtransponder is a passive device that contains an electronic circuit, which is activated externally by a low-powered radio beam sent by a handheld, battery-powered pocket reader. The microtransponder stores only a unique electronic identification number (id). The id number is used to access a database that provides the implanted person's identity and health information supplied by the patient
Product CodeNRV
Regulation Number 880.6300
Device Class 2

MDR Year MDR Reports MDR Events
2015 1 1
2018 2 2
2022 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Self-Activation or Keying 1 1
Vibration 1 1
Radiofrequency Interference (RFI) 1 1
Material Protrusion/Extrusion 1 1
Appropriate Term/Code Not Available 1 1
Patient Device Interaction Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Hearing Impairment 2 2
Pain 2 2
Burning Sensation 1 1
Twitching 1 1
Anxiety 1 1
Autoimmune Disorder 1 1

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