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

Model Number CD3371-40QC

Device Problems Application Program Version or Upgrade Problem (2881); Inappropriate or Unexpected Reset (2959)

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

Event Date 10/01/2018

Event Type  Injury  

Event Description

During follow-up, the device entered back-up vvi mode due to the cyber-security upgrade resulting in a loss of defibrillation therapy.Reprogramming attempts were performed to resolve the issue but were unsuccessful.The issue was resolved by explanting and replacing the device.The patient was in stable condition and experienced no adverse health consequences.

Manufacturer Narrative

The device was confirmed in backup vvi upon receipt.Backup vvi was caused by memory corruption in the device image.Visual inspection revealed bubbles underneath the parylene coating.The device was then cut open for analysis.Visual inspection was performed after the device was opened and no anomalies were observe.Further investigation of the device revealed noise on vdd_tel64k signal, which caused the memory corruption.The encapsulation on top of the c11 capacitor was partially removed.The noise was caused by the capacitor¿s (c11) connection in the hybrid.The hybrid¿s dhr was reviewed and no rework was done during hybrid manufacturing.

Manufacturer Narrative

Additional information: associated to z-2325-2018.The reported event of backup vvi was confirmed.The backup vvi was caused by data corruption in the device image.Electrical testing revealed an anomalous voltage signal that was found to be oscillating, which caused the data corruption.The oscillation was caused by an anomalous connection of the voltage signal¿s capacitor to the hybrid.The device history record was performed and all required manufacturing processes and inspection steps were confirmed to be completed per the requirements.The device met specifications prior to leaving abbott manufacturing facilities.

• Brand Name: QUADRA ASSURA MP ICD
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; 645 almanor avenue; sunnyvale CA 94085
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.; 645 almanor avenue; sunnyvale CA 94085
• Manufacturer Contact: robert greenleaf ; 15900 valley view court; sylmar, CA 91342 ; 8184932577
• MDR Report Key: 7952455
• MDR Text Key: 123261625
• Report Number: 2938836-2018-11264
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: P030054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 02/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2017
• Device Model Number: CD3371-40QC
• Device Lot Number: A000001663
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/05/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/12/2015
• 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-2325-2018
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention