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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOTRACE MEDICAL, INC. TEMPO TEMPORARY PACING LEAD

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BIOTRACE MEDICAL, INC. TEMPO TEMPORARY PACING LEAD Back to Search Results
Model Number T1106
Device Problem Material Fragmentation
Event Date 10/01/2019
Event Type  Malfunction  
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Brand NameTEMPO TEMPORARY PACING LEAD
Type of DeviceTEMPORARY PACING LEAD
Manufacturer (Section D)
BIOTRACE MEDICAL, INC.
3925 bohannon dr.
suite #200
menlo park CA 94025
Manufacturer (Section G)
BIOTRACE MEDICAL, INC.
3925 bohannon dr.
suite #200
menlo park CA 94025
Manufacturer Contact
ken xavier
3925 bohannon drive
suite #200
menlo park  94025
6507794999
MDR Report Key9267971
Report Number3013472601-2019-00005
Device Sequence Number1
Product CodeLDF
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial
Report Date 10/28/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received11/01/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberT1106
Device Catalogue NumberT1106
Device LOT Number31140
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer10/21/2019
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/03/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured08/22/2019
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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