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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG SELOX JT 53; PACING LEAD
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BIOTRONIK SE & CO. KG SELOX JT 53; PACING LEAD Back to Search Results
Model Number 346368
Medical Device Problem Code Naturally Worn (2988)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 09/17/2019
Type of Reportable Event Malfunction
Event or Problem Description
This atrial lead was capped during a system explant due to suspected subclavian crush.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
SELOX JT 53
Common Device Name
PACING LEAD
Manufacturer (Section D)
BIOTRONIK SE & CO. KG
woermannkehre 1
berlin 12359
MDR Report Key9109610
Report Number1028232-2019-04151
Device Sequence Number16589869
Product Code NVN
UDI-Device Identifier04035479077860
UDI-Public04035479077860
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
P950037
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2008
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date (Section B) 09/20/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Model Number346368
Device Catalogue NumberSEE MODEL NO.
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 09/20/2019
Supplement Date Received by Manufacturer09/27/2019
Initial Report FDA Received Date09/24/2019
Supplement Report FDA Received Date10/01/2019
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 Age45 YR
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