MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) QUADRA ASSURA MP ICD; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

Model Number CD3369-40C

Device Problem Fitting Problem (2183)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/02/2019

Event Type  malfunction  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in the final report.

Event Description

It was reported that the patient presented for an upgrade from a competitor implantable cardioverter-defibrillator (icd) to a crt-d system.When the leads were connected to the device and svc port was plugged, the physician noted difficulty seating the plug into the svc port.High voltage competitor right ventricular lead exhibited high, out of range, high voltage lead impedance.The device was properly programmed rv to can, and the physician checked that rv df1 pin was properly seated in the header of the device.The physician unplugged and re-plugged rv df1 pin to the device header.Competitor lead impedance was measured multiple times, and the values were within the normal range.Several minutes later, the hv impedance was measured again, and the value was high, out of range.The competitor lead was unplugged and checked through pacing system analyzer (psa) with cables, and the same issue was observed.The physician suspected damage to the competitor lead as well as an unspecified fitting issue with svc port plug of the icd.The device was not implanted and was replaced.The competitor rv lead was also replaced.All the leads were connected to the new device successfully, and all parameters were within a normal range.The patient was stable throughout the procedure.

Manufacturer Narrative

Analysis was normal.No anomalies were found.

• Brand Name: QUADRA ASSURA MP ICD
• 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: elizabeth boltz ; 15900 valley view court; sylmar, CA 91342 ; 8184932577
• MDR Report Key: 8903301
• MDR Text Key: 154635419
• Report Number: 2938836-2019-12477
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 05414734508346
• UDI-Public: 05414734508346
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P910023
• 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: 02/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2020
• Device Model Number: CD3369-40C
• Device Catalogue Number: CD3369-40C
• Device Lot Number: A000070255
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/12/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/02/2019
• Initial Date FDA Received: 08/16/2019
• Supplement Dates Manufacturer Received: 01/30/2020
• Supplement Dates FDA Received: 02/07/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/19/2018
• 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