MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. QUADRA ASSURA MP ICD; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

Model Number CD3371-40QC

Device Problem Premature Discharge of Battery (1057)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/22/2021

Event Type  Injury  

Event Description

Following the battery performance alert (bpa) advisory, a bpa was received by the clinician and the device was explanted.The patient was in stable condition.

Manufacturer Narrative

The device is included in the battery performance alert advisory issued by abbott on 28 august 2017.Further information was requested but not received.

Manufacturer Narrative

The reported field event of battery performance alert (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 consumption data.The bpa algorithm uses device usage history data for calculations, and since that data was lost during the backup vvi, a false bpa was triggered.This is normal and expected behavior when the data is cleared.Interrogation of the device revealed the device was above eri when received.No other anomaly was detected.

• Brand Name: QUADRA ASSURA MP ICD
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ABBOTT; 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: sonali arangil ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 13099012
• MDR Text Key: 282855832
• Report Number: 2017865-2021-40193
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: RO
• PMA/PMN Number: P030054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 03/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2016
• Device Model Number: CD3371-40QC
• Device Lot Number: 4749684
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/17/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/07/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-0004-2018
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention