MAUDE Adverse Event Report: ST. JUDE MEDICAL INC. FORTIFY DR; (AICD) INTERNAL DEFIBRILLATOR

Catalog Number DR2231-40Q

Device Problems Inappropriate/Inadequate Shock/Stimulation (1574); Device Issue (2379)

Patient Problem Cardiac Arrest (1762)

Event Date 07/02/2018

Event Type  Death  

Event Description

Pt admitted in full arrest secondary to multiple episodes of vf.Pt has a st jude's aicd which fired 29 times without termination of vp (prior to arrival).St jude's rep interrogated device that showed "possible high voltage lead issue.".

• Brand Name: FORTIFY DR
• Type of Device: (AICD) INTERNAL DEFIBRILLATOR
• Manufacturer (Section D): ST. JUDE MEDICAL INC. ; st. paul MN
• MDR Report Key: 8274009
• MDR Text Key: 133990037
• Report Number: 8274009
• Device Sequence Number: 1
• Product Code: LWS
• 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: 07/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: DR2231-40Q
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/02/2018
• Event Location: Hospital
• Date Report to Manufacturer: 07/17/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 70 YR