MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) UNIFY QUADRA CRT-D, US MODEL, DF4COMP; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

Model Number CD3249-40Q

Device Problems High impedance (1291); Over-Sensing (1438); Programming Issue (3014)

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

Event Date 12/08/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported the patient presented to the clinic after receiving a patient notifier.A merlin transmission revealed upper out of range high voltage lead impedance measurements.Auto mode switching episodes were observed due to far r-wave oversensing on the atrial channel.Performing a controlled shock at a cath lab and inspection for fracture were recommended.Programming changes were also recommended.No further information is available.

Manufacturer Narrative

(b)(4).

Event Description

New information received states there was reoccurrence of inappropriate auto mode switching episodes due to far r-wave oversensing.The patient had experienced fatigue and shortness of breath possibly due to atrial loss of capture.Programming changes were recommended.No procedure was completed at this time.The patient is device dependent.The patient condition remained unchanged.

• Brand Name: UNIFY QUADRA CRT-D, US MODEL, DF4COMP
• 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: jaime chavez ; 645 almanor avenue; sunnyvale, CA 94085 ; 8184934022
• MDR Report Key: 5461195
• MDR Text Key: 39051260
• Report Number: 2938836-2016-01592
• 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,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/08/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2014
• Device Model Number: CD3249-40Q
• Device Lot Number: 3754770
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/08/2015
• Initial Date FDA Received: 02/25/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/08/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/17/2012
• 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: 69 YR