MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG BIOMONITOR 2-AF; IMPLANTABLE CARDIAC MONITOR

Model Number	398493
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Discomfort (2330)
Date of Event	01/06/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
This device was removed at patient request due to complaint of discomfort.
Additional Manufacturer Narrative
Discomfort was observed following the implantation of this biotronik device.Therefore, the device as received was visually inspected.The visual inspection revealed no external anomalies.The quality documents accompanying the manufacturing process for this device were re-investigated and all production steps were performed accordingly.In particular, the final acceptance test proved the device functions to be as specified.In conclusion there was no indication of a material or manufacturing problem.

• Brand Name: BIOMONITOR 2-AF
• Common Device Name: IMPLANTABLE CARDIAC MONITOR
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin 12359
• Manufacturer Contact: 6024 jean road; lake oswego, OR 97035 ; 8772459800
• MDR Report Key: 16526089
• Report Number: 1028232-2023-01211
• Device Sequence Number: 11402182
• Product Code: MXD
• UDI-Device Identifier: 04035479135522
• UDI-Public: (01)04035479135522(17)200331
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K152995
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/21/2023

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2020
• Device Model Number: 398493
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/14/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/21/2023
• Supplement Date Received by Manufacturer: 03/30/2023
• Initial Report FDA Received Date: 03/10/2023
• Supplement Report FDA Received Date: 03/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/12/2019
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 63 YR
• Patient Sex: Unknown