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

Model Number A2DR01

Device Problem Pacing Problem (1439)

Patient Problem Fainting (1847)

Event Date 07/11/2018

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: 5076-52 lead, implanted: (b)(6) 2018.No non-health care professional.If information is provided in the future, a supplemental report will be issued.

Event Description

The patient reported that at the last device check, "they turned down the pacemaker," the patient's heart rate dropped, and the patient felt as if about to pass out.Follow-up with the physician's office did not yield any additional relevant information.The device remains in use.No further 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: 7774252
• MDR Text Key: 116862095
• Report Number: 9614453-2018-02836
• Device Sequence Number: 1
• Product Code: NVZ
• UDI-Device Identifier: 00763000059613
• UDI-Public: 00763000059613
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P980035
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/10/2018

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
• Device Expiration Date: 04/28/2019
• Device Model Number: A2DR01
• Device Catalogue Number: A2DR01
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/11/2018
• Initial Date FDA Received: 08/10/2018
• Date Device Manufactured: 11/02/2017
• 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 Age: 70 YR