MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG PROTEGO S 65; ICD LEAD

Model Number 379969

Device Problem Pocket Stimulation (1463)

Patient Problem Undesired Nerve Stimulation (1980)

Event Date 03/09/2021

Event Type  malfunction  

Event Description

It was reported that this rv lead was explanted due to diaphragmatic stimulation and replaced with an epicardial lead.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 at this time.No additional information is available at the moment.The file is closed.The investigation will be re-opened should additional data become available.

• Brand Name: PROTEGO S 65
• Type of Device: ICD LEAD
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin 12359
• MDR Report Key: 12673919
• MDR Text Key: 277684579
• Report Number: 1028232-2021-05825
• Device Sequence Number: 1
• Product Code: NVY
• UDI-Device Identifier: 04035479121488
• UDI-Public: 04035479121488
• Combination Product (y/n): N
• PMA/PMN Number: P980023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 10/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2018
• Device Model Number: 379969
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 61 YR