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

Model Number CD3357-40Q

Device Problem Pacing Inadequately (1442)

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

Event Date 01/21/2014

Event Type  malfunction  

Event Description

It was reported that right after the icd implant, intermittent capture on the rv lead was observed for a pacing dependent patient.The capture threshold was normal and the lead position was evaluated to be normal via diagnostic imaging.It was suspected that device was not providing bi-ventricular pacing output.The patient will be closely monitored.

Manufacturer Narrative

All information provided by manufacturer, no medwatch form was received.

• Brand Name: UNIFY ASSURA DR CRT-D, DF-4 CONNECTOR
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC., CRMD; 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ST. JUDE MEDICAL, INC., CRMD; 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: cary lawler ; 645 almanor avenue; sunnyvale, CA 94085 ; 8184932621
• MDR Report Key: 3665668
• MDR Text Key: 4347411
• Report Number: 2938836-2014-07959
• 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: 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2015
• Device Model Number: CD3357-40Q
• Device Catalogue Number: SMTFY999
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 01/21/2014
• Device Age: 7 MO
• Event Location: Clinic - Walk In; Other
• Initial Date Manufacturer Received: 01/21/2014
• Initial Date FDA Received: 03/06/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2013
• 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: 61 YR