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

Model Number CD3249-40Q

Device Problems Application Program Version or Upgrade Problem (2881); Inappropriate or Unexpected Reset (2959); Operating System Version or Upgrade Problem (2997)

Patient Problems Muscle Stimulation (1412); Undesired Nerve Stimulation (1980)

Event Date 08/16/2018

Event Type  malfunction  

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.

Event Description

It was reported that the patient presented in clinic for follow-up.A firmware upgrade was attempted for the implantable cardiac defibrillator.During the upgrade the device went into backup mode.The patient had phrenic nerve stimulation due to the high pacing outputs during the backup mode.The device was successfully restored and the upgrade was performed.

• Brand Name: UNIFY QUADRA CRT-D, US MODEL, DF4COMP
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: robert greenleaf ; 15900 valley view court; sylmar, CA 91342 ; 8184932577
• MDR Report Key: 7838431
• MDR Text Key: 119273155
• Report Number: 2017865-2018-13083
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 05414734504546
• UDI-Public: 05414734504546
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 10/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2013
• Device Model Number: CD3249-40Q
• Device Catalogue Number: CD3249-40Q
• Device Lot Number: 3718373
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/26/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/05/2012
• 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: 68 YR