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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG COROX OTW 75-BP; LV LEAD
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BIOTRONIK SE & CO. KG COROX OTW 75-BP; LV LEAD Back to Search Results
Model Number 354805
Medical Device Problem Code High Capture Threshold (3266)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 10/10/2019
Type of Reportable Event Malfunction
Event or Problem Description
Lv lead shows high thresholds and is programmed to 6.5v at 1.0ms.Lead remains implanted.No adverse patient events were reported.Should additional information become available, this file will be updated.
 
Additional Manufacturer Narrative
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 75-BP
Common Device Name
LV LEAD
Manufacturer (Section D)
BIOTRONIK SE & CO. KG
woermannkehre 1
berlin 12359
MDR Report Key9187453
Report Number1028232-2019-04452
Device Sequence Number2819710
Product Code OJX
UDI-Device Identifier04035479093532
UDI-Public04035479093532
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
P070008
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2008
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date (Section B) 10/10/2019
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 Number354805
Device Catalogue NumberSEE MODEL NO.
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 10/10/2019
Supplement Date Received by Manufacturer10/16/2019
Initial Report FDA Received Date10/14/2019
Supplement Report FDA Received Date10/18/2019
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 Age88 YR
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