MAUDE Adverse Event Report: MEDTRONIC EUROPE SARL PRIMO MRI VR SURESCAN; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER

Model Number	DVMD3D4
Medical Device Problem Code	Pacing Problem (1439)
Health Effect - Clinical Codes	Bradycardia (1751); Dyspnea (1816); Non specific EKG/ECG Changes (1817)
Date of Event	12/20/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the patient presented to the emergency department with shortness of breath.Pacing pauses were seen on telemetry with possible rates in the 20's were which were below the programmed lower rate of 40 beats per minute.A remote transmission indicated that the icd was currently functioning as programmed.No further patient complications have been reported as a result of this event.

• Brand Name: PRIMO MRI VR SURESCAN
• Common Device Name: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER
• Manufacturer (Section D): MEDTRONIC EUROPE SARL; route du molliau 31; case postale; tolochenaz vaud 1131 ; SZ 1131
• MDR Report Key: 11120233
• Report Number: 9614453-2021-00030
• Device Sequence Number: 11749861
• Product Code: LWS
• UDI-Device Identifier: 00763000001551
• UDI-Public: 00763000001551
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: P980016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 01/05/2021

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 11/28/2019
• Device Model Number: DVMD3D4
• Device Catalogue Number: DVMD3D4
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/20/2020
• Initial Report FDA Received Date: 01/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 6935M55 LEAD
• Outcome Attributed to Adverse Event: Other
• Patient Age: 81 YR