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

Model Number CD3357-40Q

Device Problems Difficult to Interrogate (1331); Delayed Charge Time (2586)

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

Event Date 05/26/2015

Event Type  Injury  

Event Description

It was reported that the asymptomatic patient presented in clinic after receiving an alert for the capacitor charge time limit having been reached.During attempted capacitor maintenances in-clinic the device exhibited loss of telemetry and continued capacitor charge time outs.The device was explanted and replaced.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

The reported extended charge time was confirmed in the laboratory.The device was tested on the bench as well as using automated test equipment, and no anomaly was found.The capacitors were returned to the manufacturer for further analysis and an internal capacitor anomaly was found to be the cause of the reported extended charge time.

• Brand Name: UNIFY ASSURA CRT-D RF HV
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE); 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE); 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: jaime chavez ; 645 almanor avenue; sunnyvale, CA 94085 ; 8184934022
• MDR Report Key: 4863912
• MDR Text Key: 5808938
• Report Number: 2938836-2015-27284
• Device Sequence Number: 1
• Product Code: NIK
• 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: Health Professional,User Facility,Company Representative,company representati
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/26/2015

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: 12/31/2015
• Device Model Number: CD3357-40Q
• Device Lot Number: 4385209
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/26/2015
• Initial Date FDA Received: 06/23/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/16/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/12/2013
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 76 YR