MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG COROX OTW-S 75-BP; LV LEAD

Model Number 355148

Device Problem Difficult or Delayed Positioning (1157)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/03/2019

Event Type  malfunction  

Event Description

Lv lead replaced to better position for crt.There was no crt response with bipolar lead, so physician used quadrapolar lead for better positioning.

Manufacturer Narrative

The device is currently not available for analysis.No conclusion can be drawn at this time.The investigation will be re-opened should additional data become available.

• Brand Name: COROX OTW-S 75-BP
• Type of Device: LV LEAD
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin 12359
• MDR Report Key: 8622529
• MDR Text Key: 145490824
• Report Number: 1028232-2019-02001
• Device Sequence Number: 1
• Product Code: OJX
• UDI-Device Identifier: 04035479094157
• UDI-Public: 04035479094157
• 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: 05/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2017
• Device Model Number: 355148
• Device Catalogue Number: SEE MODEL NO.
• Date Manufacturer Received: 05/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 79 YR