MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG EVITY 6 DR-T; PACEMAKER

Model Number 407149

Device Problems Failure to Capture (1081); Pacing Intermittently (1443); Low impedance (2285)

Patient Problem Dizziness (2194)

Event Date 09/20/2023

Event Type  malfunction  

Event Description

Patient was hospitalized due to pauses in pacing from spike inhibition.Failure to capture and low pacing thresholds were also noted.Device currently remains implanted.Should additional information be received, this file will be updated.

• Brand Name: EVITY 6 DR-T
• Type of Device: PACEMAKER
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin 12359 ; DE 12359
• Manufacturer Contact: 6024 jean road; lake oswego, OR 97035 ; 8772459800
• MDR Report Key: 17830795
• MDR Text Key: 324444014
• Report Number: 1028232-2023-04847
• Device Sequence Number: 1
• Product Code: NVZ
• Combination Product (y/n): N
• Reporter Country Code: DE
• 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
• Report Date: 09/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 407149
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/27/2023
• Initial Date FDA Received: 09/28/2023
• Date Device Manufactured: 03/02/2023
• 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