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

Model Number CD3249-40

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 03/15/2012

Event Type  malfunction  

Event Description

It was reported that during implant the device went into backup vvi.The physician delivered external defibrillation during dft testing, causing the device to experience a power on reset.The device was restored and remains in the field.

Manufacturer Narrative

(b)(4).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: UNIFY QUADRA CRT-D
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): ST. JUDE MEDICAL INC., CRMD; 15900 valley view ct; sylmar CA 91342
• Manufacturer (Section G): ST. JUDE MEDICAL INC., CRMD; 15900 valley view ct; sylmar CA 91342
• Manufacturer Contact: cary lawler ; 15900 valley view ct; sylmar, CA 91342 ; 8184932621
• MDR Report Key: 4092016
• MDR Text Key: 4747151
• Report Number: 2938836-2014-05099
• 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
• 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: 06/30/2013
• Device Model Number: CD3249-40
• Device Catalogue Number: SMTFY999
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 03/15/2012
• Device Age: 3 MO
• Event Location: Other
• Initial Date Manufacturer Received: 03/15/2012
• Initial Date FDA Received: 01/13/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2011
• 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