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

Model Number CD3235-40Q

Device Problem Decreased Sensitivity (2534)

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

Event Date 01/06/2012

Event Type  malfunction  

Event Description

It was reported that during implant low atrial sensing was observed.The capture and impedance were still good hence the physician chose to replace the device instead of repositioning the lead.Rv and lv values were good.The device was not implanted and replaced.

Manufacturer Narrative

All information provided by manufacturer, 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.Evaluation description: the reported low sensing was not confirmed int he laboratory.The device was tested on the bench and was subjected to interoperability and electrical testing and no anomalies were observed.The cause of the low sensing could not be determined.

• Brand Name: UNIFY QUADRA CRT-D, DF-4 CONNECTOR
• Type of Device: IMPLANTABLE CARDIOVERTER DIFIBRILLATOR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC. CRMD; 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.; 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: cary lawler ; 15900 valley view court; sylmar, CA 91342 ; 8184932621
• MDR Report Key: 3869453
• MDR Text Key: 4457684
• Report Number: 2938836-2014-02058
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2012
• Device Model Number: CD3235-40Q
• Device Catalogue Number: SMTFY999
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/13/2012
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 01/06/2012
• Device Age: 16 MO
• Event Location: Hospital
• Date Manufacturer Received: 01/06/2012
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2010
• 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: 76 YR