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	10/07/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Patient said she took cardio messenger on vacation and it looks like it exploded in her bag.The parts are separated some and its warped.Patient said it was not left in a car and it looks like it overheated.Should additional information become available, this file will be updated.
Additional Manufacturer Narrative
Upon receipt, the device was subjected to an extensive analysis.Within this analysis the device was visually, mechanically and functionally inspected.During analysis the observation could be confirmed.The device shows deformation and separation of housing components.The material characteristics of the damaged plastic parts are consistent with exposure to chemical solvents rather than thermal impact.According to our extensive analysis, the damage indicates exposure to a solvent, such as acetone.The observed swelling, cracking and discoloration of the housing as well as the deformation of the battery foil are consistent with the ingress of and this type of chemicals.Due to the volatile nature of such solvents, no residues could be detected.Based on the available findings, it is reasonable to assume that exposure to a solvent has caused the reported observation.A comprehensive analysis conducted by the manufacturer excluded battery failure as a contributing cause of the event.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.
Event or Problem Description
Patient said she took cardiomessenger on vacation and it looks like it exploded in her bag.The parts are separated some and its warped.Patient said it was not left in a car and it looks like it overheated.Should additional information become available, this file will be updated.

• Brand Name: CARDIOMESSENGER SMART 4G US
• Common Device Name: HOME MONITORING
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin 12359 ; DE 12359
• Manufacturer Contact: 6024 jean road; lake oswego, OR 97035 ; 8772459800
• MDR Report Key: 20416172
• Report Number: 1028232-2024-05335
• Device Sequence Number: 12812694
• Product Code: OSR
• UDI-Device Identifier: 04035479159115
• UDI-Public: (01)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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/10/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 438613
• Device Catalogue Number: 438613
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/07/2024
• Supplement Date Received by Manufacturer: 03/10/2026
• Initial Report FDA Received Date: 10/10/2024
• Supplement Report FDA Received Date: 03/10/2026
• 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: 55 YR
• Patient Sex: Female