MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG LINOX SMART S 65; ICD LEAD

Model Number	369818
Medical Device Problem Codes	Material Fragmentation (1261); High impedance (1291)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/06/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Combination product: yes.
Event or Problem Description
Lead showed pacing impedance over 2000.Lead attempted to be explanted but fell apart so the shock coil and tip are still in the rv.Should additional information be received, this file will b1028232-2024-04907e updated.
Additional Manufacturer Narrative
Combination product: yes.The lead is currently not available for analysis.No conclusion can be drawn based on available information at the moment.The file is closed.The investigation will be re-opened should additional data become available.

• Brand Name: LINOX SMART S 65
• Common Device Name: ICD 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: 20237827
• Report Number: 1028232-2024-04907
• Device Sequence Number: 8043153
• Product Code: NVY
• UDI-Device Identifier: 04035479112974
• UDI-Public: (01)04035479112974(17)170131
• Combination Product (Y/N): Y
• Initial Reporter Country: US
• PMA/510(K) Number: P980023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/23/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2017
• Device Model Number: 369818
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/06/2024
• Supplement Date Received by Manufacturer: 09/20/2024
• Initial Report FDA Received Date: 09/17/2024
• Supplement Report FDA Received Date: 09/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/21/2015
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 60 YR
• Patient Sex: Female