MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG COROX OTW-S 85-BP; LV LEAD

Model Number 355149

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

Patient Problems Cyst(s) (1800); Implant Pain (4561); Swelling/ Edema (4577)

Event Date 03/26/2021

Event Type  Injury  

Event Description

Lead was capped due to pocket swelling and pain caused by a large cyst on the roof of the inferior portion of the pocket.Should additional information become available, it will be added to this file.

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: COROX OTW-S 85-BP
• Type of Device: LV LEAD
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin 12359
• MDR Report Key: 11757654
• MDR Text Key: 248395946
• Report Number: 1028232-2021-02194
• Device Sequence Number: 1
• Product Code: OJX
• UDI-Device Identifier: 04035479094164
• UDI-Public: 04035479094164
• Combination Product (y/n): N
• PMA/PMN Number: P070008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 04/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 355149
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 74 YR