MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG ENTOVIS DR-T PROMRI; PACEMAKER

Model Number	371992
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Unstable Capture Threshold (3269)
Health Effect - Clinical Code	Asystole (4442)
Date of Event	11/15/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Patient was at a follow up and when the device was interrogated the patient went asystolic.When the wand was removed the patient was okay.The physician did the same thing with the same results.The device threshold report was 2.5 volts and the device was set to 1.3 volts.The device remains implanted at this time.
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.

• Brand Name: ENTOVIS DR-T PROMRI
• Common Device Name: PACEMAKER
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin 12359
• Manufacturer Contact: 6024 jean road; lake oswego, OR 97035 ; 8772459800
• MDR Report Key: 12817588
• Report Number: 1028232-2021-06265
• Device Sequence Number: 12131550
• Product Code: NVZ
• UDI-Device Identifier: 04035479115173
• UDI-Public: 04035479115173
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P950037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/15/2021

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 Expiration Date: 02/29/2016
• Device Model Number: 371992
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/15/2021
• Supplement Date Received by Manufacturer: 11/15/2021
• Initial Report FDA Received Date: 11/15/2021
• Supplement Report FDA Received Date: 11/17/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/20/2015
• 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
• Patient Sex: Female