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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG PROTEGO T 65; ICD LEAD
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BIOTRONIK SE & CO. KG PROTEGO T 65; ICD LEAD Back to Search Results
Model Number 379967
Medical Device Problem Codes Break (1069); Failure to Capture (1081)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 12/29/2020
Type of Reportable Event Malfunction
Event or Problem Description
It was reported that this lead was capped due to loss of capture and a break in lead insulation.No adverse patient events were reported.Should additional information become available, this file will be updated.
 
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.
 
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Brand Name
PROTEGO T 65
Common Device Name
ICD LEAD
Manufacturer (Section D)
BIOTRONIK SE & CO. KG
woermannkehre 1
berlin 12359
MDR Report Key11111129
Report Number1028232-2021-00008
Device Sequence Number3949975
Product Code NVY
UDI-Device Identifier04035479121686
UDI-Public04035479121686
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
P980023
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2017
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date (Section B) 12/29/2020
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 Date03/31/2019
Device Model Number379967
Device Catalogue NumberSEE MODEL NO.
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 12/29/2020
Supplement Date Received by Manufacturer01/07/2021
Initial Report FDA Received Date01/04/2021
Supplement Report FDA Received Date01/07/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Hospitalization;
Patient Age50 YR
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