MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG ETRINSA 8 HF-T; CRT-P

Model Number	394919
Medical Device Problem Code	Ambient Noise Problem (2877)
Health Effect - Clinical Codes	Bradycardia (1751); Loss of consciousness (2418)
Date of Event	04/26/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
While nurse was changing dressing, patient passed out and had no pulse, then woke up on their own with pulse around 40bpm (pacemaker programmed to 60bpm).Emt also reported 40bpm pulse.Hmsc shows no unusual behavior or episodes on that day.Pacing percentage on that day reported 100 percent.Discussed possibilities of noise from lead or external emi interfering with device.Recommended device evaluation with isometric testing.Device remains implanted.
Additional Manufacturer Narrative
The device is currently not available for analysis.No conclusion can be drawn based on available information at the moment.The file is closed.The investigation will be re-opened should additional data become available.

• Brand Name: ETRINSA 8 HF-T
• Common Device Name: CRT-P
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin 12359
• Manufacturer Contact: 6024 jean road; lake oswego, OR 97035 ; 8772459800
• MDR Report Key: 19255993
• Report Number: 1028232-2024-02518
• Device Sequence Number: 2608216
• Product Code: NKE
• UDI-Device Identifier: 04035479131777
• UDI-Public: (01)04035479131777(17)180831
• 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: 2017
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/08/2024

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: 08/31/2018
• Device Model Number: 394919
• 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: 04/30/2024
• Supplement Date Received by Manufacturer: 05/08/2024
• Initial Report FDA Received Date: 05/06/2024
• Supplement Report FDA Received Date: 05/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/10/2017
• 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 Sex: Male