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

Model Number	379967
Medical Device Problem Code	Impedance Problem (2950)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/04/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Steadily increasing pacing impedance.
Additional Manufacturer Narrative
Lead was explanted on (b)(6) 2019.Upon receipt the lead was found cut 46.5cm proximal to the lead tip.A proximal part including the serial number was missing.Explantation aids were still inserted in and mounted on the distal lead fragment.The performance of the returned lead fragment was scrutinized.During the visual analysis the ring electrode and the distal lead area were found completely covered in calcified tissue.This is assumed to be the root cause for the clinical observation of steadily increasing pacing impedance.In addition, the inspection revealed severe abrasion marks at several positions of the distal lead fragment.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.Due to the extent of the extraction damages and the tissue residuals it is assumed, that the lead was significantly ingrown which may have affected the leads motion.Further damages like the deformed rv shock coil and the from the lead tip torn passive fixation 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: PROTEGO T 65
• Common Device Name: ICD LEAD
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin 12359
• MDR Report Key: 10303027
• Report Number: 1028232-2020-03003
• Device Sequence Number: 19021121
• 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: 2017
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/22/2020

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: 04/30/2017
• Device Model Number: 379967
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2020
• Initial Date Received by Manufacturer: 07/20/2020
• Supplement Date Received by Manufacturer: 08/21/2020
• Initial Report FDA Received Date: 07/21/2020
• Supplement Report FDA Received Date: 08/25/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1