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	Fall (1848)
Date of Event	03/08/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Two alerts regarding noise on the rv channel with aborted shocks were received through hmsc.The patient reported to the md that he had fallen down a month ago while he was skiing.A new rv lead was implanted on (b)(6) 2020.
Additional Manufacturer Narrative
We received your event description for the above mentioned device and would like to thank you for supporting our post-market surveillance.As of today, the medical device is not available for analysis, therefore the device itself could not be investigated.The analysis is thus based on the inspection of the manufacturing documents of the device as well as on the provided data.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.The analysis of the provided follow up data, recorded between 3-aug-2019 and 8-mar-2020, recorded the rv sensing amplitude constantly around 20mv.The rv pacing impedance was initially recorded at 55ohms before it rose abruptly onto 1200ohms in the end of the recorded period.The analysis of the provided iegm episodes found artifacts in the rv and ff channel, which led to the reported oversensing as well as inappropriate icd charging cycles.In spite of the available information, no conclusion can be drawn regarding the root cause of the clinical observation.An analysis of the lead itself would be necessary to determine the root cause.Should additional information or the device itself become available for analysis, the investigation will be updated.

• Brand Name: PROTEGO T 65
• Common Device Name: ICD LEAD
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin 12359
• MDR Report Key: 9862701
• Report Number: 1028232-2020-01366
• Device Sequence Number: 11590095
• 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: 2016
• 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): 03/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2017
• Device Model Number: 379967
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/20/2020
• Supplement Date Received by Manufacturer: 10/09/2020
• Initial Report FDA Received Date: 03/20/2020
• Supplement Report FDA Received Date: 10/12/2020
• 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