MAUDE Adverse Event Report: ST. JUDE MEDICAL INC., CRMD UNIFY CRT-D, DF-4 CONNECTOR; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

Model Number CD3231-40Q

Device Problem Under-Sensing (1661)

Patient Problems Fall (1848); Loss of consciousness (2418)

Event Date 01/23/2012

Event Type  malfunction  

Event Description

It was reported the device exhibited intermittent undersensing.The pt loss consciousness and fell.The device remains implanted.

Manufacturer Narrative

All info provided by mfr, no medwatch form was received.This historical complaint is being filed as part of a retrospective review of complaint files in response to a recent fda inspection.There is no change to the actual performance of the product and this report only represents an enhancement to the reporting criteria going forward.

• Brand Name: UNIFY CRT-D, DF-4 CONNECTOR
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): ST. JUDE MEDICAL INC., CRMD; 15900 valley view ct; sylmar CA 91342
• Manufacturer (Section G): ST. JUDE MEDICAL INC. CRMD; 15900 valley view ct; sylmar CA 91342
• Manufacturer Contact: cary lawler ; 15900 valley view ct; sylmar, CA 91342 ; 8184932621
• MDR Report Key: 4055008
• MDR Text Key: 4901355
• Report Number: 2938836-2014-05972
• Device Sequence Number: 1
• Product Code: NIK
• 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
• Reporter Occupation: Other
• Type of Report: Initial

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: 06/30/2012
• Device Model Number: CD3231-40Q
• Device Catalogue Number: SMTFY999
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 01/23/2012
• Device Age: 14 MO
• Event Location: Other
• Initial Date Manufacturer Received: 01/23/2012
• Initial Date FDA Received: 01/14/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2010
• 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: 59 YR