MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) UNIFY ASSURA CRT-D RF HV; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

Model Number CD3357-40C

Device Problem Delayed Charge Time (2586)

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

Event Date 09/03/2019

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 when the asymptomatic patient presented during a remote transmission, an alert for a long capacitor charge time was observed.The patient was brought in-clinic for a capacitor maintenance test.Lead replacement was then discussed.

Manufacturer Narrative

Report source: company representative should not have been checked off.The results/method and conclusion codes along with investigation results will be provided in the final report.

Event Description

It was reported that when the asymptomatic patient presented during a remote transmission, an alert for a long capacitor charge time was observed.The patient was brought in-clinic for a capacitor maintenance test.Device replacement was then discussed.New information received notes that the device was explanted and replaced.There were no patient issues.

Manufacturer Narrative

The reported field event of extended charge time was confirmed in the laboratory via review of the device image.The device was tested on the bench and no anomalies were found.The high voltage capacitors were sent to the manufacturer for further analysis.The cause of the reported extended charge time was an anomalous capacitor.

• Brand Name: UNIFY ASSURA CRT-D RF HV
• 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: 9126446
• MDR Text Key: 160263114
• Report Number: 2938836-2019-14038
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 05414734508186
• UDI-Public: 05414734508186
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P970013
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 04/04/2020

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: 11/30/2018
• Device Model Number: CD3357-40C
• Device Catalogue Number: CD3357-40C
• Device Lot Number: A000031768
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/18/2019
• Initial Date FDA Received: 09/26/2019
• Supplement Dates Manufacturer Received: 10/31/2019; 04/02/2020
• Supplement Dates FDA Received: 10/31/2019; 04/04/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/10/2016
• 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