MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC., CRMD PROMOTE QUADRA; IMPLANTABLE CARDIOVERTER DEFRIBILLATOR, NIK

Model Number CD3239-40

Device Problems Difficult to Interrogate (1331); Device Operates Differently Than Expected (2913)

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

Event Date 04/03/2012

Event Type  malfunction  

Event Description

It was reported that the patient came to the hospital after an electrical storm.The cardiologist tried to interrogate the device without success.A message appeared on the screen that said cannot read the memory contact the technical services.Two buttons were on the screen, one said program, the other said send message.The cardiologist decided to push the program button and the device programmed no therapies.After that the device works well.However, the memory of the device appears to be deleted.

Manufacturer Narrative

All info provided by the mfr, no medwatch form was received.This historical complaint is being filed as part of a retrospective review of complaint files in response to a recent fda inspection.There is no change to the actual performance of the product and this report only represents an enhancement to the reporting criteria going forward.

• Brand Name: PROMOTE QUADRA
• Type of Device: IMPLANTABLE CARDIOVERTER DEFRIBILLATOR, NIK
• Manufacturer (Section D): ST. JUDE MEDICAL, INC., CRMD; 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ST. JUDE MEDICAL INC., CARDIAC RHYTHM MANAGEMENT D; 701 east evelyn ave.; sunnyvale CA 94086 652
• Manufacturer Contact: 701 east evelyn ave.; sunnyvale, CA 94086-6527 ; 8184932621
• MDR Report Key: 3891178
• MDR Text Key: 4652530
• Report Number: 2938836-2014-03573
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: DA
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,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

• Date FDA Received: 01/13/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2012
• Device Model Number: CD3239-40
• Device Catalogue Number: SMTFY999
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 04/03/2012
• Device Age: 20 MO
• Event Location: Hospital
• Date Manufacturer Received: 04/04/2012
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2010
• 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