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

Model Number	T1106
Medical Device Problem Codes	Mechanical Problem (1384); Retraction Problem (1536)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/24/2019
Type of Reportable Event	Malfunction
Event or Problem Description
(b)(6) hospital contacted biotrace medical and communicated that they had experienced a case where they had an issue with stabilizer retraction: "i have a tempo wire that the stabilizers did not retract when the md was removing the wire." there was no patient injury associated with the complaint.

• Brand Name: TEMPO TEMPORARY PACING LEAD
• Common Device Name: TEMPORARY PACING LEAD
• Manufacturer (Section D): BIOTRACE MEDICAL, INC.; 3925 bohannon dr. #200; menlo park CA 94025
• MDR Report Key: 9243283
• Report Number: 3013472601-2019-00004
• Device Sequence Number: 16547054
• Product Code: LDF
• UDI-Device Identifier: 10866899000203
• UDI-Public: 10866899000203
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K160260
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/24/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/29/2020
• Device Model Number: T1106
• Device Catalogue Number: T1106
• Device Lot Number: 31158
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/27/2019
• Initial Report FDA Received Date: 10/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 74 YR
• Patient Weight: 90