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

Model Number CD3231-40

Device Problems Inappropriate or Unexpected Reset (2959); Therapeutic or Diagnostic Output Failure (3023)

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

Event Date 01/23/2012

Event Type  malfunction  

Event Description

It was reported that during dft the device went into bvvi as a result inappropriate shocks were delivered.Patient was defibrillated externally.The device was explanted.

Manufacturer Narrative

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.Evaluation description included.The reported filed event of bvvi was confirmed in the laboratory.The cause of the reset is due to external defibrillation that was used during dft testing at implant.

• Brand Name: UNIFY CRT-D
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR, NIK
• 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 ; 15900 valley view court; sylmar, CA 91342 ; 8184932621
• MDR Report Key: 3891066
• MDR Text Key: 4678821
• Report Number: 2938836-2014-03608
• 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: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2013
• Device Model Number: CD3231-40
• Device Catalogue Number: SMTFY999
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/31/2012
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 01/23/2012
• Device Age: 5 MO
• Event Location: Hospital
• Initial Date Manufacturer Received: 01/24/2012
• Initial Date FDA Received: 01/13/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2011
• 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