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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG LINOX SMART SD 65/16; ICD LEAD
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BIOTRONIK SE & CO. KG LINOX SMART SD 65/16; ICD LEAD Back to Search Results
Model Number 359066
Medical Device Problem Codes Failure to Capture (1081); High impedance (1291)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 10/19/2021
Type of Reportable Event Malfunction
Event or Problem Description
Lead explanted due to high rv pace/sense impedance of 2900 ohms.Failure to capture at max output.No adverse patient events reported.Should additional information become available, it will be added to this file.
 
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
LINOX SMART SD 65/16
Common Device Name
ICD LEAD
Manufacturer (Section D)
BIOTRONIK SE & CO. KG
woermannkehre 1
berlin 12359
MDR Report Key12667247
Report Number1028232-2021-05810
Device Sequence Number1454350
Product Code NVY
UDI-Device Identifier04035479100391
UDI-Public04035479100391
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
Device Explanted Year2021
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date (Section B) 10/19/2021
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 Date02/28/2013
Device Model Number359066
Device Catalogue NumberSEE MODEL NO.
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 10/20/2021
Supplement Date Received by Manufacturer10/20/2021
Initial Report FDA Received Date10/20/2021
Supplement Report FDA Received Date10/20/2021
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 Age49 YR
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