MAUDE Adverse Event Report: MEDTRONIC, INC. EVERA XT DR; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER

Model Number DDBB1D1

Device Problems Failure to Interrogate (1332); Inappropriate/Inadequate Shock/Stimulation (1574); Protective Measures Problem (3015)

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

Event Date 02/03/2021

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 implantable cardioverter defibrillator (icd) experienced "issues sending transmissions".It was noted that the device had shocked the patient, however no transmission was sent.It was determined that the alerts were not programmed on in the device, therefore a transmission was not sent for shocks delivered.The implantable cardioverter defibrillator (icd) remains in use.No 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, INC.; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer (Section G): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer Contact: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 11321931
• MDR Text Key: 231612988
• Report Number: 2182208-2021-00654
• Device Sequence Number: 1
• Product Code: LWS
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/12/2021

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
• Device Operator: Lay User/Patient
• Device Model Number: DDBB1D1
• Device Catalogue Number: DDBB1D1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/03/2021
• Initial Date FDA Received: 02/12/2021
• 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