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

Model Number 407146

Device Problems Failure to Capture (1081); High Capture Threshold (3266)

Patient Problem Syncope/Fainting (4411)

Event Date 05/13/2023

Event Type  Injury  

Event Description

Patient brought into emergency room (er) after syncope and high threshold was observed.Patient brought in again later due to fainting and loss of capture was observed.Lead currently remains implanted.Should additional information be received, this file will be updated.

Manufacturer Narrative

The ipg as well as the leads under complaint were not returned.The analysis is therefore based on the received device data, as well as the inspection of relevant quality documents for the products under complaint.The manufacturing processes for the ipg as well as the leads were re-investigated, and all production steps were performed accordingly.There was no sign of any inconsistency during the manufacturing process.Particularly the final acceptance test proved the ipg as well as the leads to work as specified.The returned device data were analyzed.During interrogation on (b)(6) 2023, the ventricular pacing amplitude was 2.1 v with 0.4 ms pulse width and activated capture control.The measured threshold was 1.1 v.The safety margin was programmed to 1.0 v.The device recordings were investigated.All ventricular iegm recordings do not indicate any loss of capture.Furthermore, the recordings of the manual threshold test do not indicate non-capture below 2.4 v or 2.2 v.Therefore, the reported increase of the pacing threshold cannot be confirmed based on the available information.In summary, the device data do not indicate the occurrence of any loss of capture.The reported increase of the pacing threshold cannot be confirmed.The root cause for the syncope can therefore not be determined based on the available data.Should additional relevant information become available this investigation will be updated.

• Brand Name: EVITY 8 DR-T
• Type of Device: 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: 16967924
• MDR Text Key: 315637788
• Report Number: 1028232-2023-02517
• Device Sequence Number: 1
• Product Code: NVZ
• Combination Product (y/n): N
• PMA/PMN Number: P950037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/12/2023

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
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2024
• Device Model Number: 407146
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/17/2023
• Initial Date FDA Received: 05/19/2023
• Supplement Dates Manufacturer Received: 12/08/2023
• Supplement Dates FDA Received: 12/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/22/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization