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

Model Number CD3267-40Q

Device Problems Battery Problem (2885); Inappropriate or Unexpected Reset (2959)

Patient Problem Muscle Stimulation (1412)

Event Date 02/14/2020

Event Type  Injury  

Manufacturer Narrative

The device is included in the battery performance alert advisory issued by abbott on 28 august 2017.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 the patient experienced diaphragmatic stimulation following vibratory alerts.Backup vvi was observed (b)(6) 2020 and was addressed and resolved.The patient experienced an additional vibratory alert on (b)(6) 2020 for a battery performance alert (bpa) advisory.The device was explanted and replaced.The patient was stable.

Manufacturer Narrative

The reported field event of backup vvi was verified in the lab.However, the root cause of the reset could not be conclusively determined since the device was reprogrammed in the field and the event was not reproducible.Testing was performed and the device was found to be normal; telemetry, pacing, sensing, impedance, high voltage (hv) output, high voltage (hv) shock and patient notifier were tested on the bench.No anomaly was detected.The diaphragmatic stimulation could not be confirmed in the lab.The cause is most likely consistent with the lead positioning.The battery performance alert (bpa) was verified in the lab.However, further investigation showed the battery performance alert (bpa) was a false positive.Prior to the event, device code was reloaded in the field, which cleared the device¿s usage data as part of the procedure.The bpa algorithm uses device usage history data for calculations and since that data got cleared after reloading code, a false bpa was triggered.This is normal and expected behavior when the data is cleared and the device had been implanted for >7 years.Additional information: d10.

• 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: 9789963
• MDR Text Key: 182109994
• Report Number: 2017865-2020-02831
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 05/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2014
• Device Model Number: CD3267-40Q
• Device Lot Number: 4066927
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-0004-2018
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR