MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG LINOX SMART SD 65/18; ICD LEAD

Model Number	359067
Medical Device Problem Codes	High impedance (1291); Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/08/2022
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2022 the information about the lead identity was received.This lead was capped, left in the patient and replaced by a new one approx.117 months after the implantation.After an implantation period of approximately 20 days it was reported that the icd was explanted due to high shock impedance.A connection issue was observed between lead and icd during the explant procedure.
Additional Manufacturer Narrative
The lead was not returned for analysis.Therefore, this report is solely based on the analysis of the icd itself as well as the inspection of the quality documents associated with the manufacturing of the lead and the icd.The manufacturing processes for these devices were re-investigated and all production steps were performed accordingly.There was no sign of any inconsistency during the manufacturing.Particularly the final acceptance tests proved the devices functions to be as specified.The icd was inspected in detail.Header analysis showed that the set screw of the df-1 rv channel was fully screwed in, impeding the lead to be inserted into the header bore.However, further inspection of the set screw showed screw marks, indicating that the lead had been previously properly connected.Analysis showed no anomalies.In a next step, the icd was interrogated, revealing the bos battery status.No charging cycles were recorded to the devices memory.The inspection of the memory content confirmed the clinical observation.Therefore, the impedance measurement functions of the device were tested and proved to be normal.The clinical observation could not be reproduced.The ability of the device to deliver therapies was verified.The anti-bradycardia pacing pulses proved to be normal and in amplitude and frequency as programmed.A fibrillation signal was applied, and the device delivered a defibrillation shock as specified, documenting a normal and expected sensing and shock delivery.In particular, the specified energy level was reached, and the shock impedance was as expected.In conclusion, the memory content as well as the therapeutic functionality of the icd were thoroughly analyzed.The analysis of the memory content confirmed the clinical observation.However, an extensive analysis of the icd proved the icd to be fully functional.All measured impedance values were normal.There was no indication of device malfunction.

• Brand Name: LINOX SMART SD 65/18
• 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: 15103971
• Report Number: 1028232-2022-03782
• Device Sequence Number: 4149606
• Product Code: NVY
• UDI-Device Identifier: 04035479100407
• UDI-Public: 04035479100407
• 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: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/14/2022

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: 06/30/2014
• Device Model Number: 359067
• 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: 07/26/2022
• Supplement Date Received by Manufacturer: 10/19/2022
• Initial Report FDA Received Date: 07/26/2022
• Supplement Report FDA Received Date: 10/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/12/2012
• 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
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Unknown