MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) QUADRA ASSURA (DDQP+); IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

Model Number CD3265-40Q

Device Problems Incorrect Measurement (1383); Device Displays Incorrect Message (2591); Inappropriate or Unexpected Reset (2959)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/29/2020

Event Type  Injury  

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 a patient presented with their implantable cardioverter defibrillator (icd) that was in backup operation.The device was reprogrammed back to normal settings.The patient was stable.

Event Description

New information notes that the system exhibited a false battery performance alert (bpa) due to the reset.

Event Description

New information notes that due to the issue, the field was unable to obtain battery data and longevity estimates through direct interrogations.

Event Description

New information notes that the device was explanted due to the issues.The patient was stable.

Manufacturer Narrative

The reported field event of bpa was verified in the lab.However, further investigation showed the bpa was a false positive.Prior to the event, device had a reset, which cleared the device¿s usage data.The bpa algorithm uses device usage history data for calculations, and since that data got cleared after reset, a false bpa was triggered.This is normal and expected behavior when the data is cleared, and the device had been implanted for more than 6 years.Interrogation of the device revealed the device was above eri when received.No other anomaly was detected.The reported event or reset could not be confirmed.The device was not in backup operating mode upon receipt, additionally, a device image was not saved at the time of reset; the cause of reset could not be determined.Telemetry, impedance, sensing, pacing and high voltage (hv) output functions of the device were tested and found to be normal.

• Brand Name: QUADRA ASSURA (DDQP+)
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• MDR Report Key: 10660193
• MDR Text Key: 211050090
• Report Number: 2017865-2020-15211
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 05414734505673
• UDI-Public: 05414734505673
• Combination Product (y/n): N
• PMA/PMN Number: P030054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 04/04/2021

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2015
• Device Model Number: CD3265-40Q
• Device Catalogue Number: CD3265-40Q
• Device Lot Number: 4285344
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/29/2020
• Initial Date FDA Received: 10/11/2020
• Supplement Dates Manufacturer Received: 10/07/2020; 10/21/2020; 02/22/2021; 03/11/2021
• Supplement Dates FDA Received: 10/18/2020; 11/09/2020; 03/04/2021; 04/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 84