MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) QUADRA ASSURA MP ICD; NO MATCH

Model Number CD3371-40QC

Device Problems Environmental Compatibility Problem (2929); Inappropriate or Unexpected Reset (2959)

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

Event Date 08/01/2023

Event Type  malfunction  

Event Description

It was reported that the patient presented for follow up.An interrogation of the implantable cardioverter defibrillator revealed that the device was in backup operation due a magnetic resonance imaging (mri) scan that was performed without appropriate device settings.High voltage therapy was disabled during backup.The device was successfully reprogrammed.The patient was discharged.

Manufacturer Narrative

Correction: h6 -- "2929 - environmental compatibility problem" was missing from previous report.

• Brand Name: QUADRA ASSURA MP ICD
• Type of Device: NO MATCH
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: richard williamson ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 17597687
• MDR Text Key: 321687068
• Report Number: 2017865-2023-39018
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: P030054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2022
• Device Model Number: CD3371-40QC
• Device Lot Number: P000106438
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/31/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/17/2020
• 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