MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG KAINOX VCS 60; ICD LEAD

Model Number	124325
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that in (b)(6) 2020 the patient was in the hospital for shoulder pain (unrelated to icd system).It was discovered that the lead coil was fractured but the lead remains implanted.No adverse patient events were reported.Should additional information become available, this file will be updated.
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 explanted and returned.Upon receipt, the lead under complaint was found cut 37cm and 55cm distal to the df-1 connector pin into 3 segments.All fragments were received for analysis.It is reasonable to assume that the lead was cut during the extraction procedure.The performance of the lead fragments was scrutinized, including a visual inspection.The analysis revealed 37.5cm distal to the df-1 connector pin that the conductor coil was found fractured.Based on the characteristics, as well as the location of the damage, it is reasonable to assume that the lead was subject to excessive mechanical forces as the result of clavicular first rib entrapment.Further damages such as a deformed lead body 9cm proximal to the lead tip and a deformed rv shock coil, most likely occurred during the extraction procedure due to tensile stress.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.In conclusion, the analysis did not reveal any sign of a material or manufacturing problem.

• Brand Name: KAINOX VCS 60
• Common Device Name: ICD LEAD
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin 12359
• MDR Report Key: 10942679
• Report Number: 1028232-2020-05275
• Device Sequence Number: 16947957
• Product Code: NVY
• UDI-Device Identifier: 04035479011987
• UDI-Public: 04035479011987
• 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: 2014
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/02/2020

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: 03/31/2015
• Device Model Number: 124325
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/30/2021
• Initial Date Received by Manufacturer: 12/02/2020
• Supplement Date Received by Manufacturer: 12/08/2020; 05/21/2021
• Initial Report FDA Received Date: 12/03/2020
• Supplement Report FDA Received Date: 12/08/2020; 05/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 41 YR