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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 08/11/2019
Event Type  Injury  
Event Description

Upon removal of the lead from the patient, a pericardial effusion was noted on echocardiogram. The effusion did not require intervention. It was observed that the soft tip of the lead was detached at the midpoint of the tip.

 
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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,
Manufacturer Contact
ken xavier
3925 bohannon dr. suite #200
menlo park , CA 94025
6507794999
MDR Report Key9038803
Report Number3013472601-2019-00001
Device Sequence Number1
Product CodeLDF
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 09/12/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/13/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberT1106
Device Catalogue NumberT1106
Device LOT NumberN/A
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/13/2019
Was Device Evaluated By Manufacturer? Yes
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 09/13/2019 Patient Sequence Number: 1
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