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

Model Number A3DR01

Device Problems Failure to Capture (1081); Decreased Sensitivity (2534); Capturing Problem (2891)

Patient Problems Bradycardia (1751); Pain (1994); Dizziness (2194); Syncope/Fainting (4411)

Event Date 09/27/2021

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 patient experienced dizziness, bradycardia and syncope and sustained a fall as a result.The fall resulted in a head trauma and pain, which was treated with opiate analgesics.An x-ray also revealed a compression fracture of the l2 vertebra, which require a spinal cementoplasty to be performed.Upon device interrogation, the physician noticed a loss of ventricular capture due to atrial capture management issue, and diminished sensing of spontaneous rhythm.The device was reprogrammed and the issue was resolved.The device remains in use. no further patient complications have been reported as a result of this event.

• Brand Name: ADVISA MRI SURESCAN
• Type of Device: PULSE GENERATOR, PERMANENT, IMPLANTABLE
• Manufacturer (Section D): MEDTRONIC EUROPE SARL; route du molliau 31; case postale; tolochenaz vaud 1131 ; SZ 1131
• Manufacturer (Section G): MEDTRONIC EUROPE SARL; route du molliau 31; case postale; tolochenaz vaud 1131 ; SZ 1131
• Manufacturer Contact: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 12624923
• MDR Text Key: 276191690
• Report Number: 9614453-2021-03967
• Device Sequence Number: 1
• Product Code: NVZ
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P980035
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/13/2021

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: 11/14/2015
• 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: 10/05/2021
• Initial Date FDA Received: 10/13/2021
• Date Device Manufactured: 05/22/2014
• 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): Hospitalization; Life Threatening; Required Intervention