MAUDE Adverse Event Report: UNKNOWN DURATA; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)

Model Number DURATA

Device Problems Inappropriate/Inadequate Shock/Stimulation (1574); Device Sensing Problem (2917); Protective Measures Problem (3015)

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

Event Date 11/19/2021

Event Type  Injury  

Event Description

The patient alert sounded on (b)(6) 2021 for rv lead integrity alert (lia), only for high -rate sensing on (b)(6) 2021, multiple inappropriate high voltage therapies (shocks) were delivered upon t-wave oversensing.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: DURATA
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 17534098
• MDR Text Key: 321159479
• Report Number: MW5141001
• Device Sequence Number: 1
• Product Code: LWS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/01/2021

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?: No
• Device Model Number: DURATA
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2023
• Patient Sequence Number: 1