MAUDE Adverse Event Report: MEDTRONIC EUROPE SARL PRIMO MRI VR SURESCAN; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)

Model Number	DVMD3D4
Medical Device Problem Codes	Signal Artifact/Noise (1036); Over-Sensing (1438); Inappropriate/Inadequate Shock/Stimulation (1574)
Health Effect - Clinical Code	Shock from Patient Lead(s) (3162)
Date of Event	07/02/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a lead integrity alert (lia) was triggered for high-rate, non-sustained (hrns) episodes and sensing integrity counter (sic) and it was additionally noted that a shock was delivered by the implantable cardioverter defibrillator (icd) and that these occurred during a surgery where a magnet was not used.The icd remains in use.No further patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that a lead integrity alert (lia) was triggered for high-rate, non-sustained (hrns) episodes and sensing integrity counter (sic) and it was additionally noted that a shock was delivered by the implantable cardioverter defibrillator (icd) and that these occurred during a surgery where a magnet was not used.The icd remains in use.No further patient complications have been reported as a result of this event.

• Brand Name: PRIMO MRI VR SURESCAN
• Common Device Name: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)
• 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: 13568730
• Report Number: 9614453-2022-00539
• Device Sequence Number: 17620456
• Product Code: LWS
• UDI-Device Identifier: 00763000001551
• UDI-Public: 00763000001551
• Combination Product (Y/N): N
• 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): 02/21/2022

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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/03/2022
• Initial Report FDA Received Date: 02/21/2022
• Date Device Manufactured: 05/28/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 6935M62 LEAD
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Age: 73 YR
• Patient Sex: Male