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

Model Number	DVAB1D1
Medical Device Problem Code	Electromagnetic Interference (1194)
Health Effect - Clinical Code	Arrhythmia (1721)
Date of Event	07/17/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported by the patient that a week or so ago they were exposed to a powerful magnet, the type used to roll over the ground to pick up nails, screws and other metals, and it set off their implantable cardioverter defibrillator (icd) five to six times.The patient stated that when it happened, they pushed the magnetic roller away from them and fell to the ground and crawled away from it.Right away their heart was beating very fast continuously then it started to beat irregularly.The patient does not believe the audible alert was a magnet tone.The icd remains in use.No patient complications have been reported as a result of this event.

• Brand Name: VISIA AF XT VR
• 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: 10401422
• Report Number: 3004209178-2020-14011
• Device Sequence Number: 3860049
• Product Code: LWS
• UDI-Device Identifier: 00643169929753
• UDI-Public: 00643169929753
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P980016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 11/28/2018
• Device Model Number: DVAB1D1
• Device Catalogue Number: DVAB1D1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/24/2020
• Initial Report FDA Received Date: 08/13/2020
• 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: 6944-65 LEAD
• Patient Age: 61 YR