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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG SELOX ST 60; PACING LEAD
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BIOTRONIK SE & CO. KG SELOX ST 60; PACING LEAD Back to Search Results
Model Number 346367
Medical Device Problem Code High impedance (1291)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 09/14/2020
Type of Reportable Event Malfunction
Event or Problem Description
Rv lead had developed a steadily rising lead impedance.This lead was therefore capped and replaced by a new rv pace/sense lead on (b)(6) 2020.Should additional information be obtained, this report will be updated.
 
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 60
Common Device Name
PACING LEAD
Manufacturer (Section D)
BIOTRONIK SE & CO. KG
woermannkehre 1
berlin 12359
MDR Report Key10541183
Report Number1028232-2020-03941
Device Sequence Number3161246
Product Code NVN
UDI-Device Identifier04035479077853
UDI-Public04035479077853
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
P950037
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) 09/15/2020
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 Date03/31/2013
Device Model Number346367
Device Catalogue NumberSEE MODEL NO.
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 09/15/2020
Supplement Date Received by Manufacturer09/18/2020
Initial Report FDA Received Date09/16/2020
Supplement Report FDA Received Date09/22/2020
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 Age85 YR
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