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

Model Number 407146

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Fever (1858); Weight Changes (2607)

Event Date 04/12/2024

Event Type  Injury  

Event Description

Patient had a box-change from st jude device on (b)(6) 2022.He reportedly was very unwell over 2023, admitted to hospitals multiple times with fevers.Eventually lost 25kgs in weight, which lead to his device dropping its position and just recently leading to it protruding from the skin.Device function has been fine all along.Patient had the surgical removal of his pacemaker today (b)(6) 2024 and chronic leads were capped.Should additional information be received, this file will be updated.

• Brand Name: EVITY 8 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: 19128621
• MDR Text Key: 340446349
• Report Number: 1028232-2024-02137
• 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: 04/17/2024

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2024
• 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: 04/17/2024
• Initial Date FDA Received: 04/17/2024
• Date Device Manufactured: 09/16/2022
• 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