MAUDE Adverse Event Report: MEDTRONIC MEDTRONIC ADVISA PACEMAKER

Model Number A2DR01

Device Problem Device Inoperable (1663)

Patient Problem No Information (3190)

Event Date 12/08/2017

Event Type  Injury  

Event Description

Pacemaker generator failure.

• Brand Name: MEDTRONIC ADVISA PACEMAKER
• Type of Device: PACEMAKER
• Manufacturer (Section D): MEDTRONIC
• MDR Report Key: 7138508
• MDR Text Key: 95618416
• Report Number: MW5074156
• 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: Nurse
• Type of Report: Initial
• Report Date: 12/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: A2DR01
• 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): Life Threatening
• Patient Age: 73 YR
• Patient Weight: 92