MAUDE Adverse Event Report: ST. JUDE MEDICAL INC. QUICKFLEX; DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE

Model Number ¿

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Code Available (3191)

Event Date 09/05/2017

Event Type  malfunction  

Event Description

Male with history of a nonischemic dilated cardiomyopathy.Approximately 6 years ago, his ejection fraction was 10-15%.He underwent a biventricular pacer defibrillator implant.His ejection fraction has been stable at 45¿55 percent for the last several years.His left ventricular lead has failed approximately 10 months ago.His most recent echocardiogram was approximately 3 months ago and showed a significant decrease in his ejection fraction of 30%.The patient is having progressive cardiovascular symptoms.  he is now on maximal medical therapy.He is having a decline in his ejection fraction progressive symptoms of heart failure.

• Brand Name: QUICKFLEX
• Type of Device: DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE
• Manufacturer (Section D): ST. JUDE MEDICAL INC.; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 6940444
• MDR Text Key: 89382022
• Report Number: 6940444
• Device Sequence Number: 1
• Product Code: OJX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: ¿
• Device Catalogue Number: 1258T-86
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2017
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/15/2017
• Event Location: Hospital
• Date Report to Manufacturer: 09/15/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/11/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1