MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG SOLIA S 45; PACING LEAD

Model Number 377176

Device Problems Failure to Capture (1081); Difficult To Position (1467); Failure to Sense (1559)

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

Event Date 06/20/2018

Event Type  malfunction  

Event Description

This lead was explanted and replaced due to loss of sensing and capture, and difficulty to position.No adverse patient events were reported.Should additional information become available, this file will be updated.

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 mechanical analysis of the fixation mechanism were within the technical specifications.Further analysis of the lead did not reveal any irregularity that might have contributed to the reported clinical observations.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: SOLIA S 45
• Type of Device: PACING LEAD
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin D-123 59; GM D-12359
• MDR Report Key: 7650811
• MDR Text Key: 112740789
• Report Number: 1028232-2018-02230
• Device Sequence Number: 1
• Product Code: NVN
• UDI-Device Identifier: 04035479118259
• UDI-Public: (01)04035479118259
• Combination Product (y/n): N
• PMA/PMN Number: P950037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 06/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 377176
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2018
• Date Manufacturer Received: 10/17/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 71 YR