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 Problems Failure to Convert Rhythm (1540); Defibrillation/Stimulation Problem (1573); Output Problem (3005); Programming Issue (3014)

Patient Problems Cardiac Arrest (1762); Death (1802)

Event Date 01/10/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that a patient was coded at home for over an hour.The patient was transported to the hospital in the ccu by emt.The patient expired overnight from cardiac arrest.There is no complaint against the device; the device functioned appropriately as programmed.The patient had a vt episode and was going into and out of episodes.Therapy was delivered in several instances, atp and a shock (in separate episodes) slowing the rate enough to fall below the vt detection rate and causing a return to sinus, but not breaking the rhythm.Aborted shock was also noted.The patient remained in the vt rhythm, which slowed the vt detection zone and the device returned to sinus.An episode where the shock failed to convert the rhythm was also observed.Later, the patient went back into vt.

• 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: 6332351
• MDR Text Key: 67482248
• Report Number: 2938836-2017-15105
• 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
• Report Date: 01/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2016
• Device Model Number: CD3365-40Q
• Device Lot Number: 4629746
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/20/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/28/2014
• 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: 69 YR