MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. VISIA AF MRI S VR SURESCAN; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER

Model Number	DVFC3D1
Medical Device Problem Code	Device Sensing Problem (2917)
Health Effect - Clinical Codes	Dyspnea (1816); Ventricular Tachycardia (2132)
Date of Event	05/18/2019
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 and ventricular tachycardia (vt).The patient had to be externally cardioverted.It was also noted that the device wavelet discriminator was delaying detection of vt/ventricular fibrillation (vf) for what appeared to be true vt episodes.The device was also categorizing atrial fibrillation (af) episodes as af when they were not true af episodes.The device remains in use.No further patient complications have been reported as a result of this event.

• Brand Name: VISIA AF MRI S VR SURESCAN
• Common Device Name: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• MDR Report Key: 8708349
• Report Number: 3004209178-2019-11807
• Device Sequence Number: 11329840
• Product Code: LWS
• UDI-Device Identifier: 00643169717206
• UDI-Public: 00643169717206
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P980016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/18/2019

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: 04/28/2018
• Device Model Number: DVFC3D1
• Device Catalogue Number: DVFC3D1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/24/2019
• Initial Report FDA Received Date: 06/18/2019
• 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: 693565 LEAD
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Age: 52 YR