MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG PROTEGO T 65; ICD LEAD

Model Number	379967
Medical Device Problem Code	Ambient Noise Problem (2877)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/04/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Lead was extracted due to noise.Should additional information be received, this file will be updated.
Additional Manufacturer Narrative
Upon receipt, the lead under complaint was found cut 58 cm proximal to the lead tip.The distal fragment was received for analysis.The proximal fragment including the df4 connector pin was not returned.An extraction aid was found on the lead body, it is reasonable to assume that the lead was cut during the extraction procedure.The inspection revealed multiple signs of abrasion along the lead body.In particular the insulation in the distal end region was found rubbed through, which is assumed to be the root cause of the reported oversensing.Based on the characteristics of this damage, it is reasonable to assume that the lead had been subject to severe mechanical stress in the implanted state.Significant lead motion in the area of the tricuspid valve and interaction with atypical tissues should be taken into consideration.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: PROTEGO T 65
• 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: 12533846
• Report Number: 1028232-2021-05288
• Device Sequence Number: 11100376
• Product Code: NVY
• UDI-Device Identifier: 04035479121686
• UDI-Public: 04035479121686
• Combination Product (Y/N): N
• PMA/510(K) Number: P980023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/20/2021

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: 06/30/2019
• Device Model Number: 379967
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/24/2021
• Supplement Date Received by Manufacturer: 11/05/2021
• Initial Report FDA Received Date: 09/27/2021
• Supplement Report FDA Received Date: 11/09/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/20/2017
• 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