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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG COROX OTW-S 85-BP; LV LEAD
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BIOTRONIK SE & CO. KG COROX OTW-S 85-BP; LV LEAD Back to Search Results
Model Number 355149
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes Cyst(s) (1800); Implant Pain (4561); Swelling/ Edema (4577)
Date of Event 03/26/2021
Type of Reportable Event Serious Injury
Event or Problem Description
Lead was capped due to pocket swelling and pain caused by a large cyst on the roof of the inferior portion of the pocket.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
COROX OTW-S 85-BP
Common Device Name
LV LEAD
Manufacturer (Section D)
BIOTRONIK SE & CO. KG
woermannkehre 1
berlin 12359
MDR Report Key11757654
Report Number1028232-2021-02194
Device Sequence Number11539362
Product Code OJX
UDI-Device Identifier04035479094164
UDI-Public04035479094164
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
P070008
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) 04/27/2021
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? No
Operator of Device Health Professional
Device Model Number355149
Device Catalogue NumberSEE MODEL NO.
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 04/27/2021
Supplement Date Received by Manufacturer05/05/2021
Initial Report FDA Received Date04/30/2021
Supplement Report FDA Received Date05/07/2021
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 Age74 YR
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