MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG SENTUS PROMRI OTW QP L-85/49; LV LEAD

Model Number 408719

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Edema (1820); Fatigue (1849)

Event Date 05/14/2019

Event Type  malfunction  

Event Description

Patient presented with fatigue and bilateral lower extremity edema.This lead was found to be dislodged and was programmed off.No surgical intervention has been performed at this time, but physician is considering placing an epicardial lead.Should additional information become available, this file will be updated.

Manufacturer Narrative

On (b)(6) 2019, this lead was explanted and replaced with an epicardial lead due to dislodgement.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.

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: SENTUS PROMRI OTW QP L-85/49
• Type of Device: LV LEAD
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin 12359
• MDR Report Key: 8682970
• MDR Text Key: 147466410
• Report Number: 1028232-2019-02270
• Device Sequence Number: 1
• Product Code: OJX
• UDI-Device Identifier: 04035479148959
• UDI-Public: 04035479148959
• 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,study
• Type of Report: Initial,Followup,Followup
• Report Date: 05/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2020
• Device Model Number: 408719
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 74 YR