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

Model Number	VE60WW
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	08/12/2019
Type of Reportable Event	Malfunction
Event or Problem Description
On routine radiograph, a temporary epicardial pacing wire was found to be fractured.The exact date and time of the fracture is not known, but the pacing wire was in place for about 2.5 weeks when it was first noted by a radiologist.The patient did not require an additional lead placement or another device implant.The fractured lead remains in the patient.The patient was not having symptoms: the fractured pacing wire was discovered on routine radiograph.There have been no other known cases like this recently.

• 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: 9224507
• Report Number: 9224507
• Device Sequence Number: 19365865
• Product Code: LDF
• UDI-Device Identifier: 08718627411711
• UDI-Public: (01)08718627411711
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/01/2019
• Report Date (Section F): 10/01/2019

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: No Information
• Device Model Number: VE60WW
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 10/23/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 42 DA
• Date Report Sent to FDA: 10/01/2019