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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG LINOX SMART TD 65/16; ICD LEAD
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BIOTRONIK SE & CO. KG LINOX SMART TD 65/16; ICD LEAD Back to Search Results
Model Number 359073
Medical Device Problem Code High Capture Threshold (3266)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 01/11/2013
Type of Reportable Event Malfunction
Event or Problem Description
We were notified that this rv lead was partially capped due to high thresholds on (b)(6) 2013.Shock portion still active.No adverse patient events were reported.Should additional information become available, this file will be updated.
 
Additional Manufacturer Narrative
The lead is currently not available for analysis.No conclusion can be drawn based on available information at the moment.The file is closed.The investigation will be re-opened should additional data become available.
 
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Brand Name
LINOX SMART TD 65/16
Common Device Name
ICD LEAD
Manufacturer (Section D)
BIOTRONIK SE & CO. KG
woermannkehre 1
berlin 12359
MDR Report Key9395011
Report Number1028232-2019-05249
Device Sequence Number11258972
Product Code NVY
UDI-Device Identifier04035479100469
UDI-Public04035479100469
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
P980023
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2011
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date (Section B) 11/14/2019
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 Number359073
Device Catalogue NumberSEE MODEL NO.
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 11/14/2019
Supplement Date Received by Manufacturer12/02/2019
Initial Report FDA Received Date12/02/2019
Supplement Report FDA Received Date12/05/2019
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 Age67 YR
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