MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) FORTIFY ASSURA DR ICD, US; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

Model Number CD2357-40C

Device Problem Connection Problem (2900)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/02/2017

Event Type  malfunction  

Event Description

It was reported that during the procedure for lead revision, the physician had difficulties unscrewing the setscrew, but was able to loosen the setscrew and reposition the lead.Upon plugging the right ventricular lead back into the device, the setscrew would not tighten.A new wrench was used and the same issue was observed.The wrench was tested on the atrial setscrew and worked appropriately.The device was explanted and replaced and the lead repositioned successfully.No symptoms were reported.The patient will continue to be monitored.

Manufacturer Narrative

The reported inability to tighten the set screw was confirmed in the laboratory.The septum was removed and the setscrew was found to be stripped.The cause of reported event was due to stripped stet screw.

• Brand Name: FORTIFY ASSURA DR ICD, US
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE); 645 almanor avenue; sunnyvale CA 94085
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE); 645 almanor avenue; sunnyvale CA 94085
• Manufacturer Contact: robert greenleaf ; 15900 valley view court; sylmar, CA 91342 ; 8184932577
• MDR Report Key: 6926052
• MDR Text Key: 88776143
• Report Number: 2938836-2017-32632
• Device Sequence Number: 1
• Product Code: NVZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/21/2018

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2018
• Device Model Number: CD2357-40C
• Device Lot Number: A000020546
• Other Device ID Number: 05414734508063
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/02/2017
• Initial Date FDA Received: 10/07/2017
• Supplement Dates Manufacturer Received: 05/08/2018
• Supplement Dates FDA Received: 05/22/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/04/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: 2088TC/52, (B)(4)
• Patient Age: 44 YR