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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG PROTEGO TD 65/16; ICD LEAD
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BIOTRONIK SE & CO. KG PROTEGO TD 65/16; ICD LEAD Back to Search Results
Model Number 359076
Medical Device Problem Codes Fracture (1260); High impedance (1291); No Pacing (3268)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 11/13/2020
Type of Reportable Event Malfunction
Event or Problem Description
This rv lead was capped due to a fracture.Impedances were increasing and there was no pacing present.Should additional information be received, 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 TD 65/16
Common Device Name
ICD LEAD
Manufacturer (Section D)
BIOTRONIK SE & CO. KG
woermannkehre 1
berlin 12359
MDR Report Key11055667
Report Number1028232-2020-05608
Device Sequence Number11460322
Product Code NVY
UDI-Device Identifier04035479100490
UDI-Public04035479100490
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
P980023
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2016
Reporter Type Manufacturer
Report Source user facility
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date (Section B) 12/21/2020
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 Date12/31/2017
Device Model Number359076
Device Catalogue NumberSEE MODEL NO.
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 12/21/2020
Supplement Date Received by Manufacturer12/23/2020
Initial Report FDA Received Date12/22/2020
Supplement Report FDA Received Date12/23/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Patient Age75 YR
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