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

Model Number	DVAB1D4
Medical Device Problem Codes	Inappropriate/Inadequate Shock/Stimulation (1574); Device Sensing Problem (2917)
Health Effect - Clinical Code	Shock from Patient Lead(s) (3162)
Date of Event	12/02/2018
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 after receiving therapy from their implantable cardioverter defibrillator (icd).A remote transmission was sent.Information received on the remote transmission was reviewed by qualified personnel.It was determined that the device had misdetected atrial fibrillation with rapid ventricular response (af w/rvr) as a ventricular fibrillation (vf) episode, resulting in the patient receiving an inappropriate therapy.Follow up was conducted with the patients listed clinic.The healthcare professional (hcp) was able to verify that the patient has not been seen in-office yet and therefore, no reprogramming has been completed at this time.The device remains in use.No further patient complications have been reported as a result of this event.

• Brand Name: VISIA AF XT VR ICD
• 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: 8174886
• Report Number: 3004209178-2018-27912
• Device Sequence Number: 19493169
• Product Code: LWS
• UDI-Device Identifier: 00643169720626
• UDI-Public: 00643169720626
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/18/2018

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: 07/28/2019
• Device Model Number: DVAB1D4
• Device Catalogue Number: DVAB1D4
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/02/2018
• Initial Report FDA Received Date: 12/18/2018
• 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: 6935M62, LEAD
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Age: 89 YR