MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. (CRM-KISTA) PROMOTE QUADRA CRT-D; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

Model Number CD3239-40Q

Device Problems Under-Sensing (1661); Device Operates Differently Than Expected (2913)

Patient Problems Fainting (1847); Loss of consciousness (2418)

Event Date 02/06/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the patient lost consciousness during an episode of inappropriate automatic mode switching on the device.Patient received an av-node ablation and programming changes were made.It was also noted that atrial undersensing was also observed on the atrial channel with no reproducible noise from provocation tests.Patient was stable after the event.

• Brand Name: PROMOTE QUADRA CRT-D
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC. (CRM-KISTA); 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ST. JUDE MEDICAL, INC. (CRM-KISTA); 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: ulla strindlund ; box 7051; isafjordsgatan 15; kista SE-16-407 ; SW SE-16407 ; 4684744043
• MDR Report Key: 5514447
• MDR Text Key: 40803952
• Report Number: 3010215456-2016-01904
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/08/2016

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: 08/31/2014
• Device Model Number: CD3239-40Q
• Device Lot Number: 3963098
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/08/2016
• Initial Date FDA Received: 03/21/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/21/2013
• 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