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

Model Number CD3369-40Q

Device Problem Difficult to Interrogate (1331)

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

Event Date 02/28/2018

Event Type  malfunction  

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.

Event Description

It was reported that when an asymptomatic patient presented in clinic for a routine follow up visit, device was unable to be interrogated with two different programmers.The radio frequency antenna was removed and then the device was able to be interrogated.Patient was stable and will continue to be monitored and another troubleshooting will be attempted during the next follow up visit.Patient was presented to the clinic again on (b)(6) 2018 and a firmware download was reinstalled again and radio frequency telemetry was still not possible.The radio frequency transmitter was going to be changed for an inductive transmitter.Patient will continue to be monitored.No further information available.

Event Description

New information received on (b)(4) 2018 states that the transmitter could not communicate with the implanted device.A new transmitter was sent to the patient however the issue was not resolved.It was suspected that the device may have a radio frequency chip issue.If the communication issue is due to the radio frequency chip then the patient may go back to using his transmitter.Patient transmitter with inductive transmitter is working.An update was received on (b)(4) 2018 stating that the transmitter was able to read the implant however was unable to connect inside the patient¿s metal mobile home since patient is using a cell adapter and the metal was causing a connection issue.The cell adapter is able to connect outside of the metal mobile home.New transmitter kits were to be sent to the patient.There were no patient consequences.

• 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: robert greenleaf ; 15900 valley view court; sylmar, CA 91342 ; 8184932577
• MDR Report Key: 7382582
• MDR Text Key: 103862413
• Report Number: 2938836-2018-02832
• Device Sequence Number: 1
• Product Code: LWS
• 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
• Report Date: 12/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2019
• Device Model Number: CD3369-40Q
• Device Catalogue Number: CD3369-40Q
• Device Lot Number: A000046772
• Other Device ID Number: 05414734508377
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/28/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/31/2017
• 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 Age: 72 YR
• Patient Weight: 100