MAUDE Adverse Event Report: MEDTRONIC ATTAIN STARFIX LEAD; DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE

Model Number 0295, 4470, 4592

Device Problem Output Problem (3005)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

Device measurements have not been available since the day of implant.Battery longevity currently says: pre-implant.Device tachy therapies were not enabled, which may be the cause of the device still being in pre-implant mode.Spoke with er md, (b)(6), and stated the implant note of the device said to be downgraded from a crt-0 to a crt-p device.This is likely why the tachy detection and therapies were not turned on.Notified the rep of these findings.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: ATTAIN STARFIX LEAD
• Type of Device: DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE
• Manufacturer (Section D): MEDTRONIC
• MDR Report Key: 17533058
• MDR Text Key: 321418343
• Report Number: MW5139964
• Device Sequence Number: 1
• Product Code: OJX
• 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: 07/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Model Number: 0295, 4470, 4592
• Patient Sequence Number: 1