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

Model Number CD3365-40Q

Device Problem Defibrillation/Stimulation Problem (1573)

Patient Problems Death (1802); Ventricular Fibrillation (2130); Ventricular Tachycardia (2132); Loss of consciousness (2418)

Event Date 11/14/2016

Event Type  Death  

Manufacturer Narrative

(b)(6).

Event Description

It was reported that the patient passed away after being found unresponsive.The patient¿s wife called ems who initiated cpr, but later the patient was pronounced dead.The device was interrogated and upon review of the episodes, the device initially detected vt however the device was programmed to a vt-1 monitor zone between 160-193 bpm and the vt was occurring at 181 bpm.Within 2 minutes the patients ventricular rhythm had degenerated into either a low amplitude vf or agonal rhythm.The erratic ventricular activity was almost completely sensed appropriately but in very rare occurrences intermittent undersensing occurred due to variability in the egm amplitude.Several minutes later it was able to detect vf which caused the device to trigger a single round of atp.However before the device could charge, the degenerated rhythm caused the device to return to sinus.The ventricular activity was so low in amplitude that intermittent undersensing of the ventricular ectopic/agonal rhythm was occurring more frequently.All further episodes still present in the device memory and appeared to show the device in an atrial pace - bi-ventricular pace rhythm with apparent non-capture where it appears the patient was receiving cpr.

Manufacturer Narrative

Analysis was normal.No anomalies were found.

• Brand Name: QUADRA ASSURA CRT-D QUAD 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: 6151060
• MDR Text Key: 61621365
• Report Number: 2938836-2016-15218
• 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
• Report Date: 11/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2015
• Device Model Number: CD3365-40Q
• Device Lot Number: 4221984
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/29/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/27/2013
• 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): Death
• Patient Age: 77 YR