MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG LINOX SMART TD 65/16; ICD LEAD

Model Number	359073
Medical Device Problem Codes	Over-Sensing (1438); Inappropriate/Inadequate Shock/Stimulation (1574)
Health Effect - Clinical Code	Shock from Patient Lead(s) (3162)
Date of Event	06/08/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
After an implantation period of approx.110 months, oversensing with inappropriate therapies was reported.Apart from the shocks, no further adverse patient side effects have been reported.The lead was capped.
Additional Manufacturer Narrative
As of today, the medical device is not available for analysis, therefore the device itself could not be investigated.The analysis is thus based on the inspection of the manufacturing documents of the device as well as on the provided data.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.The analysis of the provided trend data, acquired between 12-oct-2020 and 8-jun-2021 recorded the stable pacing impedance around 500ohms with multiple intermittent increases up to 1800ohms at the end of the recording period.The analysis of the provided iegm episodes revealed artifacts on the rv channel, which led to the reported oversensing as well as inappropriate shock delivery.In spite of the available information, no conclusion can be drawn regarding the root cause of the clinical observation.An analysis of the lead itself would be necessary to determine the root cause.Should additional information or the device itself become available for analysis, the investigation will be updated.

• Brand Name: LINOX SMART TD 65/16
• Common Device Name: ICD LEAD
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin 12359
• MDR Report Key: 12013584
• Report Number: 1028232-2021-03377
• Device Sequence Number: 3425880
• Product Code: NVY
• UDI-Device Identifier: 04035479100469
• UDI-Public: 04035479100469
• Combination Product (Y/N): N
• PMA/510(K) Number: P980023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/10/2021

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 Expiration Date: 02/28/2014
• Device Model Number: 359073
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/15/2021
• Supplement Date Received by Manufacturer: 09/03/2021
• Initial Report FDA Received Date: 06/16/2021
• Supplement Report FDA Received Date: 09/13/2021
• 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