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

Model Number	438613
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	Electric Shock (2554)
Date of Event	04/03/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Device was transmitting just fine then on (b)(6) 2020 the patient felt a painful shock go through her hand when she touched the cardio messenger and then the device would no longer power on.
Additional Manufacturer Narrative
Upon receipt, the cardiomessenger smart was subjected to an extensive analysis.During the analysis of the cardiomessenger smart, the observation could not be confirmed.The cardiomessenger smart has no exposed metal parts, so it was not possible to clarify during the analysis how a painful shock for the patient could have occurred.Since the used power supply was not returned, the power supply could not be analyzed.Also, it was not possible to confirm if the power supply supplied with the cardiomessenger smart from biotronik was used.Therefore, damage caused by an incorrect power supply cannot be excluded either.The original power supply works on the secondary side with a 5 volt safety extra-low voltage.This cannot have led to an electric shock.Further analysis of the device was performed.It could be switched on, but switched off suddenly after a short time.This behavior could be traced back to a damaged component on the main circuit board, which was apparently damaged by an electrostatic pulse.This kind of damaging reinforces the assumption that the cause must be attributable to an external influence.

• Brand Name: CARDIOMESSENGER SMART 4G US
• Common Device Name: HOME MONITORING
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin 12359
• MDR Report Key: 10642323
• Report Number: 1028232-2020-04315
• Device Sequence Number: 18908214
• 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): 04/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 04/16/2020
• Initial Date Received by Manufacturer: 04/07/2020
• Supplement Date Received by Manufacturer: 10/19/2020
• Initial Report FDA Received Date: 10/07/2020
• Supplement Report FDA Received Date: 10/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1