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

Model Number DURATA

Device Problems Device Sensing Problem (2917); Impedance Problem (2950); Protective Measures Problem (3015)

Patient Problem Insufficient Information (4580)

Event Date 11/17/2021

Event Type  malfunction  

Event Description

Alert: rv lead integrity warning on (b)(6) 2021 (2 or more criteria met) review high rate-ns episodes, sensing integrity counter (short v-v intervals) and rv lead impedance.The oldest high rage-ns episode associated with this observation is dated.(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: 17531165
• MDR Text Key: 321415738
• Report Number: MW5138080
• 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: 01/05/2022

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