MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) QUADRA ASSURA (DDQP+); IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

Model Number CD3265-40

Device Problem Difficult to Interrogate (1331)

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

Event Date 04/16/2015

Event Type  Injury  

Manufacturer Narrative

The reported inability to interrogate was confirmed in the laboratory.Communication between the device and the programmer could not be established upon receipt but was restored during testing.The device was tested on the bench as well as using automated test equipment, and no anomaly was found.The cause of the reported inability to interrogate could not be determined.

Event Description

It was reported that when the patient presented in-clinic after receiving an appropriate shock, the device was unable to be interrogated.Telemetry tests were intermittently successful.The device was explanted and replaced.The patient was fine after the procedure.

Manufacturer Narrative

(b)(4).

• Brand Name: QUADRA ASSURA (DDQP+)
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE); 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE); 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: sharon mathew ; 645 almanor avenue; sunnyvale, CA 94085 ; 4085226327
• MDR Report Key: 4781545
• MDR Text Key: 13973054
• Report Number: 2938836-2015-26240
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P970013
• 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
• Report Date: 04/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2014
• Device Model Number: CD3265-40
• Device Lot Number: 4076353
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/08/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/16/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/14/2013
• 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 Outcome(s): Required Intervention
• Patient Age: 68 YR