MAUDE Adverse Event Report: PACING WIRE; ELECTRODE, PACEMAKER, TEMPORARY

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problems Bradycardia (1751); Tachycardia (2095); Asystole (4442)

Event Date 07/29/2021

Event Type  malfunction  

Event Description

After receiving report from night shift, nurse was told the v pacer wire was faulty and has a "frizzle" or opened area.This was observed when dressing was due to be changed.This patient at the time is 100% dependent and vpaced at set rate of 90 bpm.Yesterday, patient had heart rhythm issues where rate was brady/tachy/asystole and then paced.

• Brand Name: PACING WIRE
• Type of Device: ELECTRODE, PACEMAKER, TEMPORARY
• MDR Report Key: 12509806
• MDR Text Key: 273848115
• Report Number: 12509806
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 08/02/2021

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
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/02/2021
• Event Location: Hospital
• Date Report to Manufacturer: 09/21/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 24820 DA
• Patient Weight: 65