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

Model Number	359073
Medical Device Problem Code	Ambient Noise Problem (2877)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/13/2014
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lead or associated icd were not returned for analysis.The analysis is therefore based on the inspection of the quality documents associated with the manufacture of the icd as well as on the returned device data.All production steps had been performed accordingly.There was no sign of any inconsistency during the manufacturing process which might be related to the clinical observation.The final acceptance test proved the icd functions to be as specified.The returned device data have been analyzed.The analysis did not show any icd anomaly.The icd behaved as specified.Please note that the missing iegm of episode 1 is no longer available because it was overwritten by new episodes, as expected, when the memory capacity is exceeded.However, the iegm is available in the home monitoring system.Furthermore, the available iegms have been inspected in detail and revealed the presence of noise in the rv channel.This led to vf detections with shock deliveries.The pacing impedance in the rv channel increased since (b)(6), 2022 and since (b)(6), 2022 it is larger than 3000 ohms.Simultaneously the rv sensing amplitude decreased, and the rv pacing threshold increased.These are indications for a lead damage.In conclusion, the icd was not returned for analysis.The review of the quality documents confirmed a regular device manufacturing.The analysis of the returned device data revealed no indication of an icd malfunction.However, a damage of the lead cannot be excluded.
Event or Problem Description
Noise was observed on this rv lead so the icd disabled.Lead remains implanted.No adverse patient events were reported.Should additional information be received, this file 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 ; DE 12359
• Manufacturer Contact: 6024 jean road; lake oswego, OR 97035 ; 8772459800
• MDR Report Key: 14547225
• Report Number: 1028232-2022-02761
• Device Sequence Number: 12001078
• Product Code: NVY
• UDI-Device Identifier: 04035479100469
• UDI-Public: 04035479100469
• Combination Product (Y/N): N
• Initial Reporter Country: DE
• PMA/510(K) Number: P980023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/08/2022

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: 11/30/2014
• Device Model Number: 359073
• 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: 05/25/2022
• Initial Report FDA Received Date: 05/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/27/2012
• 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
• Patient Sex: Unknown