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

Model Number	379967
Medical Device Problem Code	Over-Sensing (1438)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/14/2021
Type of Reportable Event	Malfunction
Event or Problem Description
After an implantation period of approx.33 months, oversensing on the ventricular channel was reported.The lead was explanted.
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 55cm and 57cm distal to the df4 connector pin the insulation was found damaged due to wear, which is assumed to be the root cause of the reported oversensing.The characteristics of this damage indicate unexpected, excessive wear on the lead.Thus it is assumed that the lead was subject to severe mechanical stress in the implanted state.Causes for elevated stresses are difficult to determine.An accumulation of different factors may impact wear on the lead.These factors include interaction with atypical tissue, significant cardiac motion due to an adverse lead position including slack, or a potential increased ingrowth which had impact on the maneuverability of the lead.Furthermore, tortuous cardiac anatomy, high patient activity levels, and significant manual labor involving the upper body are known contributing factors.Further damages such as 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: PROTEGO T 65
• Common Device Name: ICD LEAD
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin 12359
• MDR Report Key: 11243505
• Report Number: 1028232-2021-00519
• Device Sequence Number: 14341837
• 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: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/21/2021

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: 08/31/2019
• Device Model Number: 379967
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2021
• Initial Date Received by Manufacturer: 01/27/2021
• Supplement Date Received by Manufacturer: 04/30/2021
• Initial Report FDA Received Date: 01/28/2021
• Supplement Report FDA Received Date: 05/03/2021
• 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