MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) UNIFY CRT-D; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

Model Number CD3235-40Q

Device Problems Vibration (1674); Device Displays Incorrect Message (2591)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/15/2014

Event Type  Injury  

Manufacturer Narrative

Correction: manufacturer report 2938836-2015-00999, should not have been reported as a medical device report (mdr) as the product has not been approved by fda and is part of investigation device exemption (ide).

Event Description

It was reported that the patient presented in clinic after receiving a vibratory alert.Upon review, the device was observed to have reached eri.Review of session records noted a drop in battery voltage within a very short time frame.The device was subsequently explanted.The patient was in stable condition post-procedure.

• Brand Name: UNIFY CRT-D
• 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: 7377756
• MDR Text Key: 103702635
• Report Number: 2017865-2018-04402
• Device Sequence Number: 1
• Product Code: NIK
• 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: 03/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 05/31/2012
• Device Model Number: CD3235-40Q
• Device Catalogue Number: CD3235-40Q
• Device Lot Number: 3267600
• Other Device ID Number: 05414734503563
• Date Manufacturer Received: 03/01/2018
• Date Device Manufactured: 11/16/2010
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1