TEMPO TEMPORARY PACING LEAD T1106

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-10-26 for TEMPO TEMPORARY PACING LEAD T1106 manufactured by Biotrace Medical, Inc..

MAUDE Entry Details

• Report Number: 3013472601-2019-00004
• MDR Report Key: 9243283
• Report Source: HEALTH PROFESSIONAL
• Date Received: 2019-10-26
• Date of Report: 2019-10-24
• Date of Event: 2019-09-24
• Date Mfgr Received: 2019-09-27
• Device Manufacturer Date: 2019-08-29
• Date Added to Maude: 2019-10-26
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Manufacturer Contact: MR. KEN XAVIER
• Manufacturer Street: 3925 BOHANNON DRIVE SUITE #200
• Manufacturer City: MENLO PARK CA 94025
• Manufacturer Country: US
• Manufacturer Postal: 94025
• Manufacturer Phone: 6507794999
• Manufacturer G1: BIOTRACE MEDICAL, INC.
• Manufacturer Street: 3925 BOHANNON DR. SUITE #200
• Manufacturer City: MENLO PARK CA 94025
• Manufacturer Country: US
• Manufacturer Postal Code: 94025
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: TEMPO TEMPORARY PACING LEAD
• Generic Name: TEMPORARY PACING LEAD
• Product Code: LDF
• Date Received: 2019-10-26
• Returned To Mfg: 2019-10-21
• Model Number: T1106
• Catalog Number: T1106
• Lot Number: 31158
• Operator: HEALTH PROFESSIONAL
• Device Availability: R
• Device Eval'ed by Mfgr: Y
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: BIOTRACE MEDICAL, INC.
• Manufacturer Address: 3925 BOHANNON DR. #200 MENLO PARK CA 94025 US 94025

Patients

Patient Number	Treatment	Outcome	Date
1	0		2019-10-26