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	09/08/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Patient says device and charger became hot and the port is burned.No adverse patient events were reported.Should additional information become available, this file will be updated.
Additional Manufacturer Narrative
The device is currently not available for analysis.No conclusion can be drawn at this time.No additional information is available at the moment.The file is closed.The investigation will be re-opened should additional data become available.
Additional Manufacturer Narrative
Upon receipt, the cardiomessenger was subjected to an extensive analysis.Within this analysis the device was visually, mechanically and functionally inspected.During analysis of the cardiomessenger the observation could not be confirmed.The casing as well as the charging port showed no signs of damage or heat effects.The device could be switched on properly and the battery could be charged successfully.The quality documents associated with this device were re-investigated.The review of these quality documents did not show any deviation.The power supply of the cardiomessenger was not returned for analysis and therefore could not be examined.The visual, mechanical and functional analysis revealed no indication of a material or manufacturing problem.

• 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: 12474403
• Report Number: 1028232-2021-05126
• Device Sequence Number: 11611111
• 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,Followup
• Report Date (Section B): 09/08/2021

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 09/07/2021
• Supplement Date Received by Manufacturer: 10/04/2021; 07/29/2022
• Initial Report FDA Received Date: 09/15/2021
• Supplement Report FDA Received Date: 10/07/2021; 08/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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 Age: 79 YR
• Patient Sex: Unknown