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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG LINOX SMART TD 65/18; ICD LEAD
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BIOTRONIK SE & CO. KG LINOX SMART TD 65/18; ICD LEAD Back to Search Results
Model Number 359074
Medical Device Problem Code Ambient Noise Problem (2877)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 03/12/2019
Type of Reportable Event Malfunction
Event or Problem Description
Noise was observed on this lead.P/s portion of the lead was capped and a new lead was placed.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.The investigation will be re-opened should additional data become available.
 
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Brand Name
LINOX SMART TD 65/18
Common Device Name
ICD LEAD
Manufacturer (Section D)
BIOTRONIK SE & CO. KG
woermannkehre 1
berlin 12359
MDR Report Key8542326
Report Number1028232-2019-01595
Device Sequence Number400617
Product Code NVY
UDI-Device Identifier04035479100476
UDI-Public04035479100476
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
P980023
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2012
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date (Section B) 04/22/2019
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 Model Number359074
Device Catalogue NumberSEE MODEL NO.
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 04/22/2019
Supplement Date Received by Manufacturer04/25/2019
Initial Report FDA Received Date04/23/2019
Supplement Report FDA Received Date05/20/2019
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 Age75 YR
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