MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG LINOX SMART S 60; ICD LEAD

Model Number	375012
Medical Device Problem Code	Ambient Noise Problem (2877)
Health Effect - Clinical Codes	Chest Pain (1776); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/17/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
This rv lead was explanted and replaced due to noise.No adverse patient events were reported.Should additional information be received, this file will be updated.
Additional Manufacturer Narrative
Upon receipt, a medial fragment (approximately 41cm length) was returned for analysis.The proximal fragment (including the yoke and connector pins) and the distal fragment (including the lead tip) were not returned.The performance of the lead fragment was scrutinized, including a visual inspection.The analysis revealed that the conductor cable leading to the ring electrode was found fractured, which is assumed to be the root cause of the reported oversensing.Based on the characteristics of the damages mentioned above, it is reasonable to assume that the lead had been subject to severe mechanical stress in the implanted state.Significant ingrowth of the lead which may have affected the leads motion should be taken into consideration.Diagnostic images clarifying this assumption, were not available.Damages such as cuts into the insulation and a deformed rv shock coil, most likely resulted from the extraction procedure.The manufacturing process for this device 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.
Additional 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.

• Brand Name: LINOX SMART S 60
• Common Device Name: ICD LEAD
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin 12359
• MDR Report Key: 11345948
• Report Number: 1028232-2021-00861
• Device Sequence Number: 14701662
• Product Code: NVY
• UDI-Device Identifier: 04035479116194
• UDI-Public: 04035479116194
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P980023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 375012
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2021
• Initial Date Received by Manufacturer: 02/18/2021
• Supplement Date Received by Manufacturer: 02/19/2021; 06/28/2021
• Initial Report FDA Received Date: 02/18/2021
• Supplement Report FDA Received Date: 02/19/2021; 06/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 62 YR