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

Model Number 407145

Device Problem Migration (4003)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/01/2024

Event Type  malfunction  

Event Description

Rv lead was explanted due to impedance out of range, with failure to capture consistently.Device had migrated and was upside down, far from original incision site.Physician revised device by placing it higher up and flipped right-side up.It was tied down with a stay-stitch (did not have one from original implant).Device remains implanted.No adverse patient events were reported.Should additional information become available, this file will be updated.

Manufacturer Narrative

The device is currently not available for analysis.No conclusion can be drawn based on available information at the moment.The file is closed.The investigation will be re-opened should additional data become available.

• Brand Name: EDORA 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: 18669261
• MDR Text Key: 334911389
• Report Number: 1028232-2024-00791
• Device Sequence Number: 1
• Product Code: NVZ
• 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: 02/13/2024

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 Expiration Date: 07/31/2022
• Device Model Number: 407145
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/01/2024
• Initial Date FDA Received: 02/08/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/11/2021
• 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: 80 YR
• Patient Sex: Female