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

Model Number DDBB1D1

Device Problem Invalid Sensing (2293)

Patient Problem Ventricular Tachycardia (2132)

Event Date 06/09/2018

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 presented to the emergency department (ed) 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 icd may have inappropriately withheld therapy for device classified supra ventricular tachycardia (svt) monitored episodes that appear to be true ventricular tachycardia (vt) events.Follow-up was completed with the patient¿s clinic.The allied health professional (ahp) at the clinic indicated the patient has not been seen in-office yet but does have a scheduled appointment with the physician.The physician is aware of the patients recent icd therapies, but 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: EVERA XT DR
• 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: 7659676
• MDR Text Key: 113059181
• Report Number: 3004209178-2018-14947
• Device Sequence Number: 1
• Product Code: LWS
• UDI-Device Identifier: 00643169530263
• UDI-Public: 00643169530263
• 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: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 07/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/28/2017
• Device Model Number: DDBB1D1
• Device Catalogue Number: DDBB1D1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/11/2018
• Date Device Manufactured: 06/28/2016
• 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: 4054, COMPETITOR LEAD / 0148, COMPETITOR LEAD
• Patient Outcome(s): Life Threatening
• Patient Age: 67 YR