MAUDE Adverse Event Report: BARD / C. R. BARD, INC. BARD TEMPORARY PACING ELECTRODE; ELECTRODE, PACEMAKER, TEMPORARY

Model Number 006173P

Patient Problem Failure of Implant (1924)

Event Date 10/14/2023

Event Type  Injury  

Event Description

Temporary pacing catheter became dislodged/failed.Required removal and replacement, external pacing.Refer to additional documents in i2k.

• Brand Name: BARD TEMPORARY PACING ELECTRODE
• Type of Device: ELECTRODE, PACEMAKER, TEMPORARY
• Manufacturer (Section D): BARD / C. R. BARD, INC.
• MDR Report Key: 18139898
• MDR Text Key: 328259594
• Report Number: MW5148129
• Device Sequence Number: 1
• Product Code: LDF
• UDI-Device Identifier: 00801741011207
• UDI-Public: 00801741011207
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 10/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 006173P
• Device Lot Number: GFGV1613
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 57 YR
• Patient Sex: Male
• Patient Weight: 93 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White