MAUDE Adverse Event Report: A & E MEDICAL CORPORATION MYO/WIRE TEMP PACING WIRE; ELECTRODE, PACEMAKER, TEMPORARY

Model Number 029-031

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/21/2022

Event Type  malfunction  

Event Description

Patient's atrial wires connected to the temporary pacemaker.The wire broke where it connects to the metal probe which inserts into the blue plastic hub which is then connected to the pacemaker.Patient was atrial paced at 100bpm is now nsr 66.Bp maintaining map 69.We have product to send back.

• Brand Name: MYO/WIRE TEMP PACING WIRE
• Type of Device: ELECTRODE, PACEMAKER, TEMPORARY
• Manufacturer (Section D): A & E MEDICAL CORPORATION; 5206 asbury road; farmingdale NJ 07727
• MDR Report Key: 14371166
• MDR Text Key: 291479823
• Report Number: 14371166
• Device Sequence Number: 1
• Product Code: LDF
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 029-031
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/03/2022
• Event Location: Hospital
• Date Report to Manufacturer: 05/12/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1