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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG COROX OTW 85-BP; LV LEAD
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BIOTRONIK SE & CO. KG COROX OTW 85-BP; LV LEAD Back to Search Results
Model Number 354807
Medical Device Problem Codes Break (1069); High Capture Threshold (3266)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 04/15/2019
Type of Reportable Event Malfunction
Event or Problem Description
During a gen change lv lead insulation was found to have a breach near the pin.Lead was capped and remains implanted.
 
Additional Manufacturer Narrative
(b)(6) 2019 - this lead showed high capture thresholds prior to being capped.The device is currently not available for analysis.No conclusion can be drawn at this time.The investigation will be re-opened should additional data become available.
 
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Brand Name
COROX OTW 85-BP
Common Device Name
LV LEAD
Manufacturer (Section D)
BIOTRONIK SE & CO. KG
woermannkehre 1
berlin 12359
MDR Report Key8520861
Report Number1028232-2019-01516
Device Sequence Number16519322
Product Code OJX
UDI-Device Identifier04035479093549
UDI-Public04035479093549
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
P070008
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2010
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date (Section B) 04/15/2019
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 Model Number354807
Device Catalogue NumberSEE MODEL NO.
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 04/15/2019
Supplement Date Received by Manufacturer04/30/2019
Initial Report FDA Received Date04/16/2019
Supplement Report FDA Received Date04/30/2019
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 Age87 YR
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