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

Model Number T1106

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Cardiac Arrest (1762)

Event Date 03/11/2020

Event Type  Injury  

Event Description

(b)(6) reported that they had an issue with the retention of the black connector lead during the procedure (became disconnected from the pacing generator).

• Brand Name: TEMPO TEMPORARY PACING LEAD
• Type of Device: PACING LEAD
• Manufacturer (Section D): BIOTRACE MEDICAL, INC.; 3925 bohannon dr.; suite #200; menlo park, ca
• Manufacturer (Section G): BIOTRACE MEDICAL, INC.; 3925 bohannon dr.; suite #200; menlo park, ca
• Manufacturer Contact: ken xavier ; 3925 bohannon dr.; suite #200; menlo park, ca ; 7794999110
• MDR Report Key: 9949237
• MDR Text Key: 190109214
• Report Number: 3013472601-2020-00002
• Device Sequence Number: 1
• Product Code: LDF
• UDI-Device Identifier: 00866899000203
• UDI-Public: 0866899000203
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K160260
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: T1106
• Device Catalogue Number: T1106
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/16/2020
• Initial Date FDA Received: 04/10/2020
• 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 Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 70 YR
• Patient Weight: 82