MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) FORTIFY VR, U1.6 DF1 US; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

Model Number CD1231-40

Device Problem Connection Problem (2900)

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

Event Date 12/30/2017

Event Type  malfunction  

Event Description

It was reported that during the implantation procedure, when the physician tried to insert the stylet into the inner cavity of the lead, the stylet could not be inserted.The physician elected to use another lead.The second lead could be fully inserted into the setscrew cavity of the device; however, when the physician tried to tighten the set screw, there was no noise indicating that screw was securely placed.Another device was used and the implantation procedure was completed successfully.Patient was stable.

Manufacturer Narrative

The reported set screw anomaly was confirmed in the laboratory.The is-1 set screw (b)(4) cavity was found damaged.Foreign material was found inside the set screw hex cavity that prevented full insertion of the torque driver into the hex cavity that prevented the set screw from fully tightening and prevented the lead to fully be secured.Device functionality was benched tested and no anomalies were found.

• Brand Name: FORTIFY VR, U1.6 DF1 US
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: robert greenleaf ; 15900 valley view court; sylmar, CA 91342 ; 8184932577
• MDR Report Key: 7173947
• MDR Text Key: 96702817
• Report Number: 2017865-2018-00393
• Device Sequence Number: 1
• Product Code: NVZ
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P030054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/11/2018

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: 02/28/2019
• Device Model Number: CD1231-40
• Device Lot Number: S000039094
• Other Device ID Number: 05414734504355
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/31/2017
• Initial Date FDA Received: 01/08/2018
• Supplement Dates Manufacturer Received: 10/26/2018
• Supplement Dates FDA Received: 11/11/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/23/2017
• 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
• Patient Age: 17 YR
• Patient Weight: 48