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

Model Number 024-311

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

Event Date 05/18/2023

Event Type  malfunction  

Event Description

The white temporary cardiac pacing wires by a&e medical have been problematic for three patients.Due to supply shortages we have recently switch to using the a&e wires ref 024-311.The wires fray and break away from the metal contacts.Pacing and capture fail.The wires are fragile.The level of failure that we are experiencing with this product is abnormal and occur within three days.

• Brand Name: MYO/WIRE
• Type of Device: ELECTRODE, PACEMAKER, TEMPORARY
• Manufacturer (Section D): A E MEDICAL CORPORATION; 5206 asbury road; farmingdale NJ 07727
• MDR Report Key: 17442230
• MDR Text Key: 320230140
• Report Number: 17442230
• 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: Biomedical Engineer
• Type of Report: Initial
• Report Date: 06/16/2023,06/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 024-311
• Device Catalogue Number: 024-311
• Device Lot Number: 03363
• 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: 06/16/2023
• Event Location: Hospital
• Date Report to Manufacturer: 08/02/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 10 DA
• Patient Sex: Male