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

Model Number 407145

Device Problem Failure to Capture (1081)

Patient Problems Atrial Fibrillation (1729); Cardiac Arrest (1762); Ventricular Fibrillation (2130)

Event Date 08/03/2023

Event Type  malfunction  

Event Description

Pt with af & chb.Physician placed a temp pacer for generator change.Generator change without event.All numbers within normal limits, patient was pacing appropriately.Shortly after, patient coded.Device was interrogated while lab staff was doing cpr/chest compressions.Impedances still normal, so programmed voo 80 max outputs and no capture, but ekg appeared to be fine vf.After attempting to pace with a temp pacer through groin and no capture again, lab staff shocked patient.Patient returned to pacing.Patient then had several minutes of slow vt (with perfusion) and eventually converted after lab administered amiodarone.Once patient back in af and not vt/vf, assessed pacing again and all numbers still within normal limits.Left with implanted pacer functioning and temp as backup.Patient transferred to icu.Patient was vented but stable.On (b)(6) 2023, device was checked.All device function and lead tests were within normal limits, and patient was pacing appropriately.However, patient was still unresponsive on the ventilator.Device remains implanted.Should additional information become available, this file will be updated.

• Brand Name: EDORA 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: 17497621
• MDR Text Key: 320894084
• Report Number: 1028232-2023-04028
• Device Sequence Number: 1
• Product Code: NVZ
• UDI-Device Identifier: 04035479147648
• UDI-Public: (01)04035479147648(17)240531
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P950037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 407145
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/04/2023
• Date Device Manufactured: 11/30/2022
• 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
• Patient Age: 89 YR