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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 Capture Threshold (3266)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 02/21/2020
Type of Reportable Event Malfunction
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.
 
Event or Problem Description
After a review of our records, this event was recognized as reportable to the competent authority.The patient implanted with this lead was placed on homemonitoring due to increasing ventricular threshold.The patient is pacemaker dependent.The threshold rose over 3v and it was decided to replace the lead.A new lead (solia) and a new pacemaker were implanted on (b)(6) 2020.This selox lead was capped and remains in situ.
 
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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
DE  12359
MDR Report Key10825616
Report Number1028232-2020-04884
Device Sequence Number11564260
Product Code NVN
UDI-Device Identifier04035479077853
UDI-Public04035479077853
Combination Product (Y/N)N
Initial Reporter CountryDE
PMA/510(K) Number
P950037
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2015
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 02/24/2020
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 Date11/30/2016
Device Model Number346367
Device Catalogue NumberSEE MODEL NO.
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 11/10/2020
Initial Report FDA Received Date11/11/2020
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;
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