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

Model Number	379967
Medical Device Problem Code	High impedance (1291)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/12/2020
Type of Reportable Event	Malfunction
Event or Problem Description
After an implantation period of approx.27 months, it was observed that the impedance of the rv lead is too high.Both leads lv and rv lead were removed and replaced.
Additional Manufacturer Narrative
Upon receipt, the lead under complaint was subjected to an extensive analysis.The performance of the lead was scrutinized, including a visual and electrical inspection.The analysis showed multiple abrasion marks along the lead.In particular the insulation in the distal end was end was found rubbed through.However, this damage is not considered to be the root cause of the reported high lead impedance.Further analysis of the lead did not show any deviations which might have led to the reported high pacing impedance.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.Damages such as a deformed rv shock coil and ruptured tines from the lead tip, most likely occurred due to the mechanical forces applied during the extraction procedure.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
• MDR Report Key: 10996485
• Report Number: 1028232-2020-05461
• Device Sequence Number: 3737730
• 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: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/18/2020

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: 05/31/2020
• Device Model Number: 379967
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2020
• Initial Date Received by Manufacturer: 12/11/2020
• Supplement Date Received by Manufacturer: 03/03/2021
• Initial Report FDA Received Date: 12/12/2020
• Supplement Report FDA Received Date: 03/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization