MAUDE Adverse Event Report: A & E MEDICAL CORPORATION MYO/WIRE ULTRA-THIN TEMPORARY PACING WIRES; ELECTRODE, PACEMAKER, TEMPORARY

Model Number	V605PBB
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/20/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Temporary epicardial pacer wires were placed during cardiac surgery on the day of the surgery.After three days from the surgery, radiology report noted a fractured pacer wire overlying the upper abdomen.It is unknown how pacer wire fractured.The risk of removal was determined to be greater than if it remained.

• Brand Name: MYO/WIRE ULTRA-THIN TEMPORARY PACING WIRES
• Common Device Name: ELECTRODE, PACEMAKER, TEMPORARY
• Manufacturer (Section D): A & E MEDICAL CORPORATION; 5206 asbury road; farmingdale NJ 07727
• MDR Report Key: 10546365
• Report Number: 10546365
• Device Sequence Number: 11639754
• Product Code: LDF
• UDI-Device Identifier: 08718627411537
• UDI-Public: (01)08718627411537
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/31/2020
• Report Date (Section F): 08/31/2020

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: No Information
• Device Model Number: V605PBB
• Device Catalogue Number: V605PBB
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 09/17/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 08/31/2020