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

Model Number VE60WW

Device Problem Fracture (1260)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 08/12/2019

Event Type  malfunction  

Event 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
• Type of Device: ELECTRODE, PACEMAKER, TEMPORARY
• Manufacturer (Section D): A E MEDICAL CORPORATION; 5206 asbury road; farmingdale NJ 07727
• MDR Report Key: 9224507
• MDR Text Key: 163334018
• Report Number: 9224507
• Device Sequence Number: 1
• Product Code: LDF
• UDI-Device Identifier: 08718627411711
• UDI-Public: (01)08718627411711
• 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: 10/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: VE60WW
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/01/2019
• Event Location: Hospital
• Date Report to Manufacturer: 10/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 42 DA