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

Model Number	359066
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/25/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The first complaint information was received on (b)(6) 2022.After update received on (b)(6)2022 the lead was identified and it was decided to report the event associated with it.After an estimated implantation period of approx.99 months, it was observed that the svc coil of the lead is damaged.The icd was re-programmed.
Additional Manufacturer Narrative
The icd and the lead were not returned for analysis.The analysis is therefore based on the inspection of the quality documents associated with the manufacture of these particular devices as well as on the returned icd data.The manufacturing processes for the icd and the lead were re-investigated.All production steps had been performed accordingly.There was no sign of any inconsistency during the manufacturing processes.The final acceptance tests proved the devices functions to be as specified.The returned data have been analyzed.Analysis showed a slightly elevated current consumption.The root cause was not determinable, but it most likely resulted from the registered low lead impedance values.A thorough inspection of the data revealed no indication of an icd malfunction.Furthermore, analysis showed intermittent oor values of the shock impedance ( greater than 150 ohms) and rv pacing impedance values less than 200 ohms.Based on these observations as well as the clinical observation, it is reasonable to assume that the reported event resulted from a damage of the rv lead.In conclusion, the devices were not returned for analysis.The review of the quality documents confirmed a regular device manufacturing.The analysis of the returned data revealed no indication of an icd malfunction.The integrity of the lead cannot be assured.

• Brand Name: LINOX SMART SD 65/16
• 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: 13573248
• Report Number: 1028232-2022-00901
• Device Sequence Number: 4363504
• Product Code: NVY
• UDI-Device Identifier: 04035479100391
• UDI-Public: 04035479100391
• Combination Product (Y/N): N
• PMA/510(K) Number: P980023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/31/2022

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: 08/31/2015
• Device Model Number: 359066
• 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: 02/21/2022
• Supplement Date Received by Manufacturer: 04/20/2022
• Initial Report FDA Received Date: 02/21/2022
• Supplement Report FDA Received Date: 04/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/15/2013
• 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