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

Model Number CD3249-40

Device Problems False Alarm (1013); Device Operates Differently Than Expected (2913)

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

Event Date 11/17/2013

Event Type  malfunction  

Event Description

New information received notes that a device parameter error was observed.Device was reprogrammed.The patient will continue to be monitored.

Event Description

It was reported that the patient received a transmission for back up vvi via merlin.Net.Upon further investigation, it was noted that the backup vvi transmission was inappropriate.The device was not found in back up vvi and operating in normal condition with no further issues.Normal monitoring will continue.

Manufacturer Narrative

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

• Brand Name: UNIFY QUADRA CRT-D
• 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: 4030671
• MDR Text Key: 4758186
• Report Number: 2938836-2014-14697
• 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,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2013
• Device Model Number: CD3249-40
• Device Catalogue Number: SMTFY999
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/22/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/21/2012
• 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: 77 YR