MAUDE Adverse Event Report: ABBOTT QUADRA ASSURA MP ICD; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

Model Number CD3371-40C

Device Problem Battery Problem (2885)

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

Event Date 02/21/2023

Event Type  Injury  

Event Description

It was reported that a low remaining batter longevity was observed on the device following implant.Abbott technical support (ts) was stated the event could be due to a interrogation that was performed a year prior while the device was still in it's packaging.A new interrogation was performed and the longevity increased, however, ts recommended to replaced the device as the longevity could not be trusted.No intervention has been performed at this time to resolve the event.The patient was in stable condition and will continue to be monitored.

Event Description

Additional information received indicated the device was explanted and replaced to resolve the event.The patient was in stable condition.

Manufacturer Narrative

The reported event of premature battery depletion was confirmed.Interrogation of the device revealed the device was above elective replacement indicator (eri) voltage level when received.A longevity calculation was performed and revealed the battery depletion was premature based on the device usage.Electrical testing was performed and revealed high current drain from the hybrid.An anomalous hybrid was revealed to be the root cause of the high current drain and premature battery depletion.

• Brand Name: QUADRA ASSURA MP ICD
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• 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: 16564934
• MDR Text Key: 311499598
• Report Number: 2017865-2023-13997
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: SZ
• 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,Followup
• Report Date: 05/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2023
• Device Model Number: CD3371-40C
• Device Lot Number: A000118631
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/21/2023
• Initial Date FDA Received: 03/17/2023
• Supplement Dates Manufacturer Received: 03/20/2023; 04/28/2023
• Supplement Dates FDA Received: 04/04/2023; 05/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/30/2021
• 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
• Patient Outcome(s): Required Intervention