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

Model Number 386836

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

Patient Problems Cardiac Tamponade (2226); Cardiac Perforation (2513); Pericardial Effusion (3271)

Event Date 05/08/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

This lead was attempted but not implanted because the target vessel dissected during the attempt.This lead was returned with documentation from the hospital stating that the patient had pericardial tamponade and there was a successful emergent pericardiocentesis and resolution of the pericardial effusion.

Manufacturer Narrative

Upon receipt, the lead under complaint was subjected to an extensive analysis.The performance of the lead was scrutinized, including a visual, mechanical and electrical inspection.In the course of the analysis, no deviations were noted.The lead proved to be without fault throughout its inspection.In particular, the values of the parameters measured during the electrical analysis were within the technical specifications.Further analysis of the lead did not reveal any irregularity that might have contributed to the reported clinical observation.The manufacturing process for this lead was re-investigated.All production steps had been performed accordingly.There was no sign of any inconsistency during the manufacturing process.In conclusion, the analysis did not reveal any sign of a material or manufacturing problem.Biotronik monitors the post-market performance of its products closely in order to identify any trends that may reveal over time a potential manufacturing or design issue.The historic performance of the product involved in the current case does not at this point reveal any such trend.

• Brand Name: SENTUS OTW QP L-85
• Type of Device: LV LEAD
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin D-123 59; GM D-12359
• Manufacturer Contact: 6024 jean road; lake oswego, OR 97035 ; 8772459800
• MDR Report Key: 6591839
• MDR Text Key: 76011522
• Report Number: 1028232-2017-01651
• Device Sequence Number: 1
• Product Code: OJX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P070008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 386836
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/16/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/01/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/11/2017
• 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: 74 YR