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 Under-Sensing (1661)

Patient Problems Death (1802); Myocardial Infarction (1969); Ventricular Fibrillation (2130); Ventricular Tachycardia (2132)

Event Date 02/24/2017

Event Type  Death  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the patient received new device after elective removal of an advisory icd.The patient was stable post-procedure and discharged later that day.Later that evening, the patient passed away.Upon interrogation of the device, it was noted that the patient was having what looked like a vt/vf storm, which the device responded to with appropriate therapy.It went on for about an hour and towards the end there was intermittent undersensing.Meanwhile, during the time of the episodes, the patient was being brought back via ems and they chose not to perform resuscitation.The physician surmised that the device responded appropriately and delivered effective therapy.The subsequent events were indicative of an infarction induced vf storm.

Manufacturer Narrative

Analysis was normal.No anomalies were found.

• 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: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517564470
• MDR Report Key: 6405857
• MDR Text Key: 69991980
• Report Number: 2938836-2017-18334
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/29/2019

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: 12/31/2018
• Device Model Number: CD3357-40C
• Device Catalogue Number: CD3357-40C
• Device Lot Number: A000033128
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/28/2017
• Initial Date FDA Received: 03/15/2017
• Supplement Dates Manufacturer Received: Not provided; 03/28/2019
• Supplement Dates FDA Received: 03/22/2017; 03/29/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/14/2016
• 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): Death
• Patient Age: 72 YR