MAUDE Adverse Event Report: MEDTRONIC, INC. MEDTRONIC DUAL CHAMBER TEMPORARY EXTERNAL PACEMAKER ; PULSE - GENERATOR, PACEMAKER, EXTERNAL

Model Number 5392

Device Problem Pacing Intermittently (1443)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/11/2019

Event Type  Injury  

Event Description

Pt was being 100% paced using medtronic dual chamber temporary pacemaker when the device abruptly stopped functioning.Clinician noted "error 0810" message on screen instructing them to contact medtronic.Device was taken out of service, new temporary pacemaker placed on pt.Pt did not suffer any adverse outcome as a result of this event.Device had recently been calibrated by medtronic in december 2018.

• Brand Name: MEDTRONIC DUAL CHAMBER TEMPORARY EXTERNAL PACEMAKER
• Type of Device: PULSE - GENERATOR, PACEMAKER, EXTERNAL
• Manufacturer (Section D): MEDTRONIC, INC.
• MDR Report Key: 8439805
• MDR Text Key: 139472923
• Report Number: MW5085061
• Device Sequence Number: 1
• Product Code: DTE
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/19/2019

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
• Device Operator: Health Professional
• Device Model Number: 5392
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/20/2019
• 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: 65 YR
• Patient Weight: 122