MAUDE Adverse Event Report: MEDTRONIC MEDTRONIC; DUAL CHAMBER TEMPORARY PACEMAKER

Model Number 5392

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/17/2017

Event Type  Injury  

Event Description

Temporary external pacemaker set to emergency asynchronous mode.No harm to pt due to staff quick assessment.Emergency button location and ease of initiation not ideal.Have had 3 reported events of this nature where asynchronous pacing was initiated either incidentally by staff or pt.A plastic cover or relocation of this button with a deterrent or at minimum of mode change is recommended.

• Brand Name: MEDTRONIC
• Type of Device: DUAL CHAMBER TEMPORARY PACEMAKER
• Manufacturer (Section D): MEDTRONIC
• MDR Report Key: 6950997
• MDR Text Key: 89511667
• Report Number: MW5072760
• Device Sequence Number: 1
• Product Code: DTE
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 10/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 5392
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 54 YR