MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG LINOX SMART SD 60/16; ICD LEAD

Model Number	359065
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/02/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Lead partially capped.Rv p/s pin capped during changeout procedure.While connecting the rv p/s pin into the new device, the physician engaged the set screw for the pin electrode and did a tug test to ensure the lead was properly secured.The insulation between the ring and the tip broke loose and the conductor for the tip unraveled.The lead was clipped distal to the ring electrode and the remaining lead body was capped pending extraction at a later date.No adverse patient events reported.Should additional information become available, it will be added to this file.
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.
Additional Manufacturer Narrative
Lead was extracted on (b)(6) 2021.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.
Additional Manufacturer Narrative
Lead was extracted on (b)(6) 2021.Upon receipt, the lead under complaint was found cut 4 cm distal to the is-1 connector pin.The proximal fragment was received for analysis.The yoke and the distal fragment including the shock coils and lead tip was not returned.It is reasonable to assume that the lead was cut during the surgery.The analysis revealed a damaged insulation directly next to the is-1 connector pin.In this region the inner coil was found deformed.The above mentioned damages most likely resulted due to mechanical stress during the extraction procedure.Prior to the analysis of the device, the quality documents accompanying the manufacturing process for this device were re-investigated.All production steps were performed accordingly, and in particular the final acceptance test proved the device functions to be as specified.In conclusion, the analysis did not reveal any sign of a material or manufacturing problem.

• Brand Name: LINOX SMART SD 60/16
• 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: 12972004
• Report Number: 1028232-2021-06617
• Device Sequence Number: 17276705
• Product Code: NVY
• UDI-Device Identifier: 04035479100384
• UDI-Public: 04035479100384
• 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: 2013
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 12/02/2021

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: 07/31/2014
• Device Model Number: 359065
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/02/2021
• Supplement Date Received by Manufacturer: 12/14/2021; 12/23/2021; 03/10/2022
• Initial Report FDA Received Date: 12/09/2021
• Supplement Report FDA Received Date: 12/15/2021; 01/04/2022; 03/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/30/2012
• 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 Age: 47 YR
• Patient Sex: Female