MAUDE Adverse Event Report: 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	06/24/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Lead explanted due to high rv pacing impedance current measurement at >3000 ohms.No adverse patient events reported.Should additional information become available, it will be added to this file.
Additional Manufacturer Narrative
The device is currently not available for analysis.No conclusion can be drawn at this time.No additional information is available at the moment.The file is closed.The investigation will be re-opened should additional data become available.
Additional Manufacturer Narrative
Upon receipt, the lead under complaint was found cut 57cm 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 surgery.The analysis revealed that the distal end region of the returned fragment was covered in fibriotic growth.Calcifications are known to cause high impedances and is thus assumed to be the root cause of the reported high pacing impedance.Further damages such as a deformed rv shock coil, most likely resulted from the extraction procedure.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
• MDR Report Key: 12378785
• Report Number: 1028232-2021-04827
• Device Sequence Number: 3924866
• Product Code: NVY
• UDI-Device Identifier: 04035479121686
• UDI-Public: 04035479121686
• 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: 2017
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/24/2021

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: 10/31/2018
• Device Model Number: 379967
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2021
• Initial Date Received by Manufacturer: 08/26/2021
• Supplement Date Received by Manufacturer: 08/31/2021; 10/28/2021
• Initial Report FDA Received Date: 08/27/2021
• Supplement Report FDA Received Date: 09/01/2021; 11/02/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/17/2016
• 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: 71 YR