MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) FORTIFY DR, U1.6 SJ4 US; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

Model Number CD2231-40Q

Device Problem Difficult to Interrogate (1331)

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

Event Date 06/05/2014

Event Type  Injury  

Manufacturer Narrative

The initial medical device report was submitted (2938836-2014-14880).Lithium clusters were observed during the analysis.No additional analysis is necessary.

Event Description

It was reported that the device was explanted after multiple attempts to interrogate the device could not be established.There were no adverse consequences to the patient.

• Brand Name: FORTIFY DR, U1.6 SJ4 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: 7376015
• MDR Text Key: 103644312
• Report Number: 2017865-2018-04349
• Device Sequence Number: 1
• Product Code: LWS
• Combination Product (y/n): N
• PMA/PMN Number: P030054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial
• Report Date: 03/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 12/31/2011
• Device Model Number: CD2231-40Q
• Device Lot Number: 3155635
• Other Device ID Number: 05414734504386
• Date Manufacturer Received: 03/01/2018
• Date Device Manufactured: 06/20/2010
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 68 YR