MAUDE Adverse Event Report: MEDTRONIC EUROPE SARL ADVISA DR MRI SURESCAN; PULSE GENERATOR, PERMANENT, IMPLANTABLE

Model Number A3DR01

Device Problem Invalid Sensing (2293)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/10/2017

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the implantable pulse generator (ipg) device exhibited false atrial fibrillation (at)/ atrial fibrillation (af) detection.Reprogramming was performed.The device remains in use.No patient complications have been reported as a result of this event.

• Brand Name: ADVISA DR MRI SURESCAN
• Type of Device: PULSE GENERATOR, PERMANENT, IMPLANTABLE
• Manufacturer (Section D): MEDTRONIC EUROPE SARL; route du molliau 31; case postale; tolochenaz vaud 1131 ; CH 1131
• Manufacturer (Section G): MEDTRONIC EUROPE SARL; route du molliau 31; case postale; tolochenaz vaud 1131 ; CH 1131
• Manufacturer Contact: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 7094428
• MDR Text Key: 94667925
• Report Number: 9614453-2017-04561
• Device Sequence Number: 1
• Product Code: NVZ
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: P980035
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/28/2014
• Device Model Number: A3DR01
• Device Catalogue Number: A3DR01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/09/2017
• Initial Date FDA Received: 12/07/2017
• Date Device Manufactured: 04/29/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention