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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG SELOX ST 53; PACING LEAD
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BIOTRONIK SE & CO. KG SELOX ST 53; PACING LEAD Back to Search Results
Model Number 346366
Medical Device Problem Codes High impedance (1291); High Capture Threshold (3266)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 09/20/2021
Type of Reportable Event Malfunction
Event or Problem Description
Lead capped due to acute rise in threshold and pacing impedance.Impedance rose to 2,145 ohms from 624 ohms at last follow up.Capture threshold went from 2.2v at 0.4ms last follow up, to 6v at 0.4ms.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
SELOX ST 53
Common Device Name
PACING LEAD
Manufacturer (Section D)
BIOTRONIK SE & CO. KG
woermannkehre 1
berlin 12359
MDR Report Key12533908
Report Number1028232-2021-05280
Device Sequence Number1350518
Product Code NVN
UDI-Device Identifier04035479077846
UDI-Public04035479077846
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
P950037
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2013
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date (Section B) 09/20/2021
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 Date02/28/2014
Device Model Number346366
Device Catalogue NumberSEE MODEL NO.
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 09/20/2021
Supplement Date Received by Manufacturer09/28/2021
Initial Report FDA Received Date09/27/2021
Supplement Report FDA Received Date09/28/2021
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 Age87 YR
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