MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) UNIFY QUADRA CRT-D, US MODEL, DF4COMP; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

Model Number CD3249-40Q

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Aortic Regurgitation (1716); Endocarditis (1834); Unspecified Infection (1930); Inflammation (1932); First Use Syndrome (2239); Cardiogenic Shock (2262); Discomfort (2330); Low Cardiac Output (2501); No Code Available (3191); Multiple Organ Failure (3261)

Event Date 11/23/2017

Event Type  Injury  

Manufacturer Narrative

Analysis was normal.No anomalies were found.(b)(4).

Event Description

It was reported that the pacer-dependent patient developed an infection; endocarditis and septic emboli were noted.The patient presented to the hospital for discomfort which progressed to severe back pain.Medical imaging revealed inflammation of the lumbar and spine regions of the patient, and blood cultures were positive.It was noted that the patient experienced cardiogenic shock, aortic regurgitation, and low blood pressure.The patient was given pressor agents, required emergency intubation, and was developing multi-organ failure.On (b)(6) 2017 the system was explanted and replaced.The patient¿s condition was noted to be marginal.

• Brand Name: UNIFY QUADRA CRT-D, US MODEL, DF4COMP
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: robert greenleaf ; 15900 valley view court; sylmar, CA 91342 ; 8184932577
• MDR Report Key: 7188500
• MDR Text Key: 97268339
• Report Number: 2017865-2018-00701
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 01/12/2018

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2013
• Device Model Number: CD3249-40Q
• Device Catalogue Number: CD3249-40Q
• Device Lot Number: 3645196
• Other Device ID Number: 05414734504546
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/21/2017
• Initial Date FDA Received: 01/12/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/14/2012
• 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: 78 YR
• Patient Weight: 104