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	07/12/2021
Type of Reportable Event	Malfunction
Event or Problem Description
This previously abandoned lead was attempted to be extracted due to a fracture, however was unsuccessful.Part was removed and part remains in the patient.No adverse patient events reported.Should additional information become available, it will be added to this file.
Additional Manufacturer Narrative
Upon receipt, the lead under complaint was found cut 47 cm distal to the is 1 connector pin.The proximal fragment was received for analysis.The distal fragment including the lead tip was not returned.It is reasonable to assume that the lead was cut during the surgery.The analysis showed that the insulation was found damaged due to wear between 18 cm and 23 cm distal to the is 1 connector pin.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 interaction with the generator housing.Further damages such as a bent is-1 connector pin, most likely resulted from 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: KAINOX VCS 60
• 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: 12600618
• Report Number: 1028232-2021-05515
• Device Sequence Number: 3373515
• 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: 2011
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/14/2021

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 Model Number: 124325
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/14/2021
• Supplement Date Received by Manufacturer: 01/13/2022
• Initial Report FDA Received Date: 10/08/2021
• Supplement Report FDA Received Date: 01/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/15/2009
• 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: 44 YR
• Patient Sex: Male