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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG COROX OTW-L 75-BP; LV LEAD

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BIOTRONIK SE & CO. KG COROX OTW-L 75-BP; LV LEAD Back to Search Results
Model Number 368345
Device Problem Ambient Noise Problem (2877)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/09/2021
Event Type  malfunction  
Event Description
Possible noise on lv near field.No far field visible for review.Full lead evaluation recommended.Lead remains implanted.No adverse patient events were reported.Should additional information become available, this file will be updated.
 
Manufacturer Narrative
Clinician reported noise on the lead, seen causing crt interrupt recordings on home monitoring.The noise can be recreated when the patient reaches across their torso and pushes their hands together.Clinician will review with physician and continue to monitor the lead.Lead remains implanted.No adverse patient events were reported.Should additional information become available, this file will be updated.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.
 
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-L 75-BP
Type of Device
LV LEAD
Manufacturer (Section D)
BIOTRONIK SE & CO. KG
woermannkehre 1
berlin 12359
MDR Report Key11302927
MDR Text Key231023744
Report Number1028232-2021-00710
Device Sequence Number1
Product Code OJX
UDI-Device Identifier04035479112165
UDI-Public04035479112165
Combination Product (y/n)N
PMA/PMN Number
P070008
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup,Followup
Report Date 02/09/2021
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
Device Operator Health Professional
Device Expiration Date09/30/2013
Device Model Number368345
Device Catalogue NumberSEE MODEL NO.
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 02/09/2021
Initial Date FDA Received02/09/2021
Supplement Dates Manufacturer Received02/15/2021
05/05/2021
Supplement Dates FDA Received02/17/2021
05/07/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age66 YR
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