MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG SOLIA S 60; PACING LEAD

Model Number 377179

Device Problem Insufficient Information (3190)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 12/27/2023

Event Type  malfunction  

Event Description

This lead was explanted due to left bundle failure between tip and ring.Tip broke free during explant and will remain in svc.Should additional information be received, this file will be updated.

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.

Manufacturer Narrative

Upon receipt, the lead under complaint was received for analysis.The lead tip was not returned.The analysis showed that the suture sleeve was found damaged and the conductor coil deformed 25 cm distal to the is-1 connector pin, which most likely resulted from a tight suture sleeve during the implantation procedure.Furthermore, cuts into the insulation and a deformed conductor coil were found 28 cm distal to the is-1 connector pin.These damages probably occurred during the surgery.Prior to the analysis of the device, the quality documents accompanying the manufacturing process for this device were re-investigated.All production steps were performed accordingly, and in particular the final acceptance test proved the device functions to be as specified.In conclusion, the analysis did not reveal any sign of a material or manufacturing problem.

• Brand Name: SOLIA S 60
• Type of Device: PACING LEAD
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin 12359
• Manufacturer Contact: 6024 jean road; lake oswego, OR 97035 ; 8772459800
• MDR Report Key: 18443835
• MDR Text Key: 331892821
• Report Number: 1028232-2024-00033
• Device Sequence Number: 1
• Product Code: NVN
• UDI-Device Identifier: 04035479118273
• UDI-Public: (01)04035479118273(17)240531
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P950037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 04/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2024
• Device Model Number: 377179
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/27/2023
• Initial Date FDA Received: 01/04/2024
• Supplement Dates Manufacturer Received: 01/05/2024; 04/12/2024
• Supplement Dates FDA Received: 01/09/2024; 04/12/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/12/2022
• 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: 90 YR
• Patient Sex: Female