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

Model Number CD3251-40Q

Device Problems Over-Sensing (1438); Inappropriate/Inadequate Shock/Stimulation (1574); Decreased Sensitivity (2534)

Patient Problems Therapeutic Effects, Unexpected (2099); Shock from Patient Lead(s) (3162)

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 the patient experienced an inappropriate shock due to intermittent lead noise and t-wave oversensing.Programming changes were made.The patient presented to the hospital for a defibrillation test.After the test, the patient experienced another inappropriate shock due to oversensing.There was no anomaly on the x-ray.Low r-waves were noted from the past two months.The device was explanted and replaced.There were no adverse consequences to the patient prior, during and post procedure.

Manufacturer Narrative

The reported field event of t-wave oversensing and inappropriate therapy was confirmed in the laboratory due to review of programmer printout.The device was tested on the bench and no anomalies were found.

• Brand Name: UNIFY QUADRA CRT-D, OUS MODEL, DF4COMP
• 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: robert greenleaf ; 15900 valley view court; sylmar, CA 91342 ; 8184932577
• MDR Report Key: 7670093
• MDR Text Key: 113427237
• Report Number: 2938836-2018-08499
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P030054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/11/2018

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: 07/31/2014
• Device Model Number: CD3251-40Q
• Device Catalogue Number: CD3251-40Q
• Device Lot Number: 3919339
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/03/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/13/2018
• Initial Date FDA Received: 07/09/2018
• Supplement Dates Manufacturer Received: 11/02/2018
• Supplement Dates FDA Received: 11/11/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/17/2013
• 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
• Treatment: 7121Q/58, (B)(4)
• Patient Outcome(s): Required Intervention
• Patient Age: 75 YR