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	02/15/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Patient says the housing of the monitor is swollen, like heat has made it expand.No adverse patient events were reported.Should additional information be received, this file will be updated.
Additional Manufacturer Narrative
Upon receipt, the cardio messenger smart was subjected to an extensive analysis.Within this analysis the device was visually, mechanically and functionally inspected.The analysis of the cardio messenger smart did not reveal any indication of a device malfunction.The device could be switched on properly and the battery could be charged successfully.The housing did not show any signs of damage or heat effects.The quality documents associated with this device were re-investigated.The review of these quality documents did not show any deviation.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: 13638774
• Report Number: 1028232-2022-00966
• Device Sequence Number: 20137588
• 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): 02/15/2022

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/15/2022
• Supplement Date Received by Manufacturer: 07/26/2022
• Initial Report FDA Received Date: 03/01/2022
• Supplement Report FDA Received Date: 07/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/31/2020
• 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: 56 YR
• Patient Sex: Male