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

Model Number DVBB1D4

Device Problems Pacing Problem (1439); Inappropriate/Inadequate Shock/Stimulation (1574); Device Sensing Problem (2917)

Patient Problem Palpitations (2467)

Event Date 11/12/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the patient presented to the emergency department due to feeling palpitations.A remote transmission was sent.Information received on the remote transmission was reviewed by qualified personnel.It was determined that the implantable cardioverter defibrillator (icd) had detected atrial fibrillation with rapid ventricular response (af w/rvr) as a ventricular tachycardia (vt) episode resulting in the patient receiving inappropriate anti-tachycardia pacing (atp) therapy.The device remains in use.No further patient complications have been reported as a result of this event.

• Brand Name: EVERA XT VR
• 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: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 10802535
• MDR Text Key: 215426227
• Report Number: 3004209178-2020-19508
• Device Sequence Number: 1
• Product Code: LWS
• UDI-Device Identifier: 00643169017948
• UDI-Public: 00643169017948
• 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
• Report Date: 11/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/28/2016
• Device Model Number: DVBB1D4
• Device Catalogue Number: DVBB1D4
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/26/2020
• Date Device Manufactured: 10/07/2014
• 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
• Patient Age: 55 YR
• Patient Weight: 86