MAUDE Adverse Event Report: INFINITE BIOMEDICAL TECHNOLOGIES LLC ELEMENT SYSTEM WITH IBT ELECTRODES; CUTANEOUS ELECTRODE

Device Problem No Apparent Adverse Event (3189)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

It was reportefd by the prosthetist that patient was wearing the device and reported that the electrodes were getting warm and that he thought they just needed to be replaced.When the prosthetist evaluated the prosthesis, he powered on, and the electrodes felt warm and therefore replaced the electrodes.There was no patient injury.

Manufacturer Narrative

Infinite biomedical technologies is submitting the information to comply by 21cfr 803.This report is based on the information received by infinite biomedical technologies llc (refered to as ibt hereafter), which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Ibt has made reasonable efforts to obtain more complete information and has provided as much relevant information as available to the company as of the submission date of this report.Following are the sections that ibt is currently working on to obtain more information on: a1-a6 - patient information.B3 - date of the event.D4 - additional device information.D10 - suspected medical devices - concomitant therapy products and medical dates.H4 - device manufactured date.

Manufacturer Narrative

Infinite biomedical technologies is submitting the information to comply by 21cfr 803.This report is based on the information received by infinite biomedical technologies llc (refered to as ibt hereafter), which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Ibt has made reasonable efforts to obtain more complete information and has provided as much relevant information as available to the company as of the submission date of this report.Ibt was informed that the device has been discarded by the clinic and we will not be able to send the system for investigation.Therefore, ibt will not be able to provide the following information.

Manufacturer Narrative

Infinite biomedical technologies is submitting the information to comply by 21cfr 803.This report is based on the information received by infinite biomedical technologies llc (reffered to as ibt hereafter), which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Ibt has made reasonable efforts to obtain more complete information and has provided as much relevant information as available to the company as of the submission date of this report.Ibt made reasonable efforts to request the practitoner for the following information, but no response was received on this matter.Therefore, ibt will not be able to provide any additional information.A1-a6 - patient information.B3 - date of the event.D10 - suspected medical devices - concomitant therapy products and medical dates.

• Brand Name: ELEMENT SYSTEM WITH IBT ELECTRODES
• Type of Device: CUTANEOUS ELECTRODE
• Manufacturer (Section D): INFINITE BIOMEDICAL TECHNOLOGIES LLC; 8 market place; suite 500; baltimore MD 21202 4264
• Manufacturer (Section G): INFINITE BIOMEDICAL TECHNOLOGIES LLC; 8 market place; suite 500; baltimore MD 21202 4264
• Manufacturer Contact: rahul kaliki ; 8 market place; suite 500; baltimore, MD 21202-4264 ; 4434517175
• MDR Report Key: 17924544
• MDR Text Key: 325530665
• Report Number: 3004426795-2023-00001
• Device Sequence Number: 1
• Product Code: GXY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K173571
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/13/2023
• Initial Date FDA Received: 10/12/2023
• Supplement Dates Manufacturer Received: 09/13/2023; 09/13/2023
• Supplement Dates FDA Received: 11/10/2023; 12/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1