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

Model Number 407157

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Wound Dehiscence (1154); Unspecified Infection (1930); Implant Pain (4561)

Event Date 07/20/2023

Event Type  Injury  

Event Description

System explanted due to patient complaint of pain, wound dehiscence and infection.Should additional information become available, this file will be updated.

Manufacturer Narrative

Infection was observed following the implantation of this biotronik device.The sterilization process was investigated.The validated process assures that all sterilization parameters, such as gas concentration, temperature, humidity, etc., are within its specified ranges for each distributed device.Additionally an analysis of validated microbiological indicators is performed after every sterilization procedure as evidence of successful completion of the sterilization process.Review of the biotronik complaint database did not reveal any changes regarding the trend for this type of incident.In summary, the infection was not device related.

• Brand Name: EDORA 8 SR-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: 17606269
• MDR Text Key: 321772251
• Report Number: 1028232-2023-04234
• Device Sequence Number: 1
• Product Code: NVZ
• UDI-Device Identifier: 04035479147761
• UDI-Public: (01)04035479147761(17)220930
• 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: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/23/2023

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2022
• Device Model Number: 407157
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/29/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/16/2023
• Initial Date FDA Received: 08/23/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/10/2021
• 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: 89 YR
• Patient Sex: Female