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

Model Number CD3365-40Q

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

Patient Problems Arrhythmia (1721); Congestive Heart Failure (1783)

Event Date 09/14/2017

Event Type  Injury  

Event Description

It was reported that the patient was admitted to hospital due to chronic right sided middle back pain since several weeks with worsening shortness of breath and edema.The patient has past medical history of cardiomyopathy with ejection fraction of 10-15%, chronic atrial fibrillation, hypertension, hypothyroidism, degenerative joint disease, gastrointestinal bleed.Patient was being treated with iv lasix, entresto, beta blockers, eliquis, pravastatin.Patient had daily labs drawn, ct checked, and ekg performed.Patient's device was reprogrammed due to chronic atrial fibrillation and patient was discharged on (b)(6) 2017.It was also noted that the patient had atrial/ventricular arrhythmia and chronic heart failure exacerbation.Generator change was discussed.No further information was reported.

Manufacturer Narrative

This supplemental report is to correct the initial mdr reported report type: product problem, and type of reportable event: malfunction which was submitted on october 23, 2017.The report type and type of reportable event were erroneously submitted as there was no complaint of device malfunction.The correct report type is adverse event and type of reportable event is serious injury.

Event Description

Additional information received noted that there is no known allegation of a malfunction and/or adverse event experienced by the patient as a result of an abbott/st.Jude medical device.

Event Description

New information received noted that the patient's implantable cardioverter defibrillator was explanted and replaced with a biv device on (b)(6) 2017.Physician upgraded patient's device to help chronic heart failure with multi-point pacing algorithm.The leads were compatible with new device and in excellent function.Patient was discharged from the hospital.

Manufacturer Narrative

Interrogation of the device revealed it was above eri when received. based on this information, the device was found to communicate appropriately with a merlin programmer and has not reached the elective replacement indicator (eri).

• Brand Name: QUADRA ASSURA CRT-D QUAD RF HV
• 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: 6970846
• MDR Text Key: 90400924
• Report Number: 2017865-2017-33532
• 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,Followup,Followup
• Report Date: 05/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2017
• 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 Catalogue Number: CD3365-40Q
• Device Lot Number: 4228067
• Other Device ID Number: 05414734508292
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/16/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/31/2013
• 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): Other
• Patient Age: 77 YR
• Patient Weight: 70