MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC., CRMD UNIFY QUADRA CRT-D, DF-4 CONNECTOR; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

Model Number CD3249-40Q

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

Patient Problems Unspecified Infection (1930); Staphylococcus Aureus (2058); Sepsis (2067)

Event Date 01/17/2015

Event Type  Injury  

Event Description

It was reported that the patient developed an infection.The patient was hospitalized with sepsis and staph infection.The system was removed without any complications.

Event Description

New information received notes that the patient had generalized weakness, dyspnea, worsening exertion and cough.

Manufacturer Narrative

All information provided by manufacturer, no medwatch form was received.Analysis was normal.No anomaly was found.

Manufacturer Narrative

(b)(4).

• Brand Name: UNIFY QUADRA CRT-D, DF-4 CONNECTOR
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC., CRMD; 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ST. JUDE MEDICAL, INC., CRMD; 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: sharon mathew ; 645 almanor avenue; sunnyvale, CA 94085 ; 4085226327
• MDR Report Key: 4583826
• MDR Text Key: 5451424
• Report Number: 2938836-2015-02589
• 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 Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2014
• Device Model Number: CD3249-40Q
• Device Catalogue Number: SMTFY999
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/28/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/25/2013
• 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
• Treatment: (B)(4)
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR