MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) UNIFY QUADRA CRT-D, US MODEL, DF1COMP; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

Model Number CD3249-40

Device Problem Failure to Deliver Shock/Stimulation (1133)

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

Event Date 12/11/2018

Event Type  Injury  

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 a generator change was performed.All device/lead diagnostics appeared normal upon interrogation of new device.A dft was attempted at rv-svc and can and device failed to delivery therapy and then it was switched to rv-can with successful return to sinus.There were multiple dfts due to failed attempts, needing lead explant and new insertion.

Event Description

New information notes that the reason for generator change was due to eri.The svc coil was most likely the issue.The alert was delivered when the physician performed a manual shock.There was no actual evidence showing svc malfunction the only evidence is the fact that it was able to convert using an rv coil to can configuration.The patient condition was stable.

Manufacturer Narrative

The device was tested on the bench and no anomalies were found.

• Brand Name: UNIFY QUADRA CRT-D, US MODEL, DF1COMP
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE); 645 almanor avenue; sunnyvale CA 94085
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE); 645 almanor avenue; sunnyvale CA 94085
• Manufacturer Contact: elizabeth boltz ; 15900 valley view court; sylmar, CA 91342 ; 8184932577
• MDR Report Key: 8192750
• MDR Text Key: 131299937
• Report Number: 2938836-2018-13303
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 05414734504539
• UDI-Public: 05414734504539
• 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,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/25/2019

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: 08/31/2013
• Device Model Number: CD3249-40
• Device Catalogue Number: CD3249-40
• Device Lot Number: 3632221
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/11/2018
• Initial Date FDA Received: 12/21/2018
• Supplement Dates Manufacturer Received: 03/06/2019; 03/23/2019
• Supplement Dates FDA Received: 03/21/2019; 03/25/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/28/2012
• 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 Outcome(s): Required Intervention
• Patient Weight: 83