MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG CARDIOMESSENGER SMART 4G US; HOME MONITORING

Model Number	438613
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/24/2021
Type of Reportable Event	Malfunction
Event or Problem Description
This cardiomessenger was returned.Where the power cord connects to the device, it is burnt.No adverse patient events were reported.Should additional information become available, this file will be updated.
Additional Manufacturer Narrative
Upon receipt, the cardiomessenger including the power supply was subjected to an extensive analysis.Within this analysis the device was visually, mechanically and functionally inspected.During the analysis of the cardiomessenger and the power supply the observation could be confirmed.The usb socket showed signs of heating and the usb plug of the power supply had fused with the usb socket of the cardiomessenger.The heating damage could be traced back to a contamination of the usb socket.The manufacturing process for this device was re-investigated.All production steps had been performed accordingly.There was no sign of any inconsistency during the manufacturing process, which might be related to the clinical observation.The information you provided has been entered into our quality system as a complaint.These types of complaints are used to evaluate systems and device performance throughout our organization and help to maintain and improve the performance of our devices.

• Brand Name: CARDIOMESSENGER SMART 4G US
• Common Device Name: HOME MONITORING
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin 12359
• Manufacturer Contact: 6024 jean road; lake oswego, OR 97035 ; 8772459800
• MDR Report Key: 12541235
• Report Number: 1028232-2021-05339
• Device Sequence Number: 11089955
• Product Code: OSR
• UDI-Device Identifier: 04035479159115
• UDI-Public: 04035479159115
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P050023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/24/2021

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
• Operator of Device: Health Professional
• Device Model Number: 438613
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/24/2021
• Supplement Date Received by Manufacturer: 07/29/2022
• Initial Report FDA Received Date: 09/28/2021
• Supplement Report FDA Received Date: 08/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/04/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Male