MAUDE Adverse Event Report: ABBOTT QUADRA ASSURA MP ICD; NO MATCH

Model Number CD3371-40QC

Device Problems Incorrect Measurement (1383); Compatibility Problem (2960)

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

Event Date 08/24/2023

Event Type  malfunction  

Event Description

It was reported that following an magnetic resonance imaging (mri) scan, incorrect data regarding longevity was noted on the device.Abbott technical support was contacted and the temporary incorrect data was suspected to be due to diagnostic data clearing when programming the device into mri enabled mode.Upon re-interrogation, the correct measurements were noted on the device and no intervention was required.The patient was in stable condition.

Manufacturer Narrative

It was reported that there was a longevity discrepancy following an magnetic resonance imaging (mri) scan.The device was not returned for analysis; however, session records were provided for review.The presented high current following mri was due to an inappropriate handling of the hom event (high output event).

• Brand Name: QUADRA ASSURA MP ICD
• Type of Device: NO MATCH
• Manufacturer (Section D): ABBOTT; 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ABBOTT; 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: richard williamson ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 17694799
• MDR Text Key: 322780950
• Report Number: 2017865-2023-42288
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 09/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2021
• Device Model Number: CD3371-40QC
• Device Lot Number: P000096385
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/15/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/08/2020
• 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
• Treatment: DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR; QUARTET; TENDRIL STS