MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG ETRINSA 8 DR-T; PACEMAKER

Model Number	394931
Medical Device Problem Code	Battery Problem (2885)
Health Effect - Clinical Code	Syncope/Fainting (4411)
Date of Event	07/05/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Patient had a syncopal episode.A battery error was received upon interrogation.Patient was advised to follow up with the device clinic asap.Device currently remains implanted.Should additional information be received, this file will be updated.
Additional Manufacturer Narrative
The clinic reported that the patient was seen in clinic for a device interrogation on 6-26-23 by the device nurse.Rv lead is programmed unipolar sensing and pacing.Battery is 45 percent and shows 4 yr, 6 mo.Thresholds, sensing and impedance were all within normal limits on last check.She remains 0 percent rv paced.The device was not returned for analysis.The analysis is therefore based on the inspection of the quality documents associated with the manufacture of this particular device as well as on the available data.The manufacturing process for this device was re-investigated.All production steps had been performed accordingly.There was no sign of any inconsistency during the manufacturing process.The final acceptance test proved the device functions to be as specified.The available home monitoring and follow-up data have been analyzed.The analysis did not show any anomalies of this pacemaker, in particular regarding the battery status.However, based on the data, a lead damage cannot be excluded.In conclusion, the device was not returned for analysis.The review of the quality documents confirmed a regular device manufacturing.The analysis of the available data revealed no indication of a device malfunction.
Additional Manufacturer Narrative
The clinic reported that the patient was seen in clinic for a device interrogation on (b)(6) 2023 by the device nurse.Rv lead is programmed unipolar sensing and pacing.Battery is 45 percent and shows 4 yr, 6 mo.Thresholds, sensing and impedance were all within normal limits on last check.She remains 0 percent rv paced.

• Brand Name: ETRINSA 8 DR-T
• 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: 17312922
• Report Number: 1028232-2023-03511
• Device Sequence Number: 3957340
• Product Code: NVZ
• UDI-Device Identifier: 04035479131821
• UDI-Public: (01)04035479131821(17)160731
• 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: Consumer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/02/2023

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2016
• Device Model Number: 394931
• 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: 07/05/2023
• Supplement Date Received by Manufacturer: 07/14/2023; 08/01/2023
• Initial Report FDA Received Date: 07/12/2023
• Supplement Report FDA Received Date: 07/14/2023; 08/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/23/2015
• 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 Age: 67 YR
• Patient Sex: Female