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

Model Number DVFB1D4

Device Problems Inappropriate/Inadequate Shock/Stimulation (1574); Invalid Sensing (2293)

Patient Problem Shock from Patient Lead(s) (3162)

Event Date 06/04/2018

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the patient was shocked by the implantable cardioverter defibrillator (icd), possibly due to atrial fibrillation (af) with rapid ventricular response.The device remains in use.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

The device was later explanted and replaced when the patient received a crt-d device.

Manufacturer Narrative

The device was returned and analyzed.Returned product analysis was performed and no anomalies were found.If information is provided in the future, a supplemental report will be issued.

• Brand Name: VISIA MRI AF XT VR ICD
• Type of Device: 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
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 7639360
• MDR Text Key: 112383718
• Report Number: 3004209178-2018-14398
• Device Sequence Number: 1
• Product Code: LWS
• UDI-Device Identifier: 00643169929913
• UDI-Public: 00643169929913
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P980016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 09/20/2018

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
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/28/2019
• Device Model Number: DVFB1D4
• Device Catalogue Number: DVFB1D4
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/04/2018
• Initial Date FDA Received: 06/26/2018
• Supplement Dates Manufacturer Received: 07/30/2018; 09/11/2018
• Supplement Dates FDA Received: 08/10/2018; 09/20/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/09/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: 6935M62 LEAD
• Patient Outcome(s): Life Threatening
• Patient Age: 74 YR