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

Model Number CD3371-40QC

Device Problems Failure to Deliver Shock/Stimulation (1133); Incorrect Interpretation of Signal (1543); Under-Sensing (1661)

Patient Problem Death (1802)

Event Date 10/24/2020

Event Type  Death  

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.

Event Description

It was reported that ventricular fibrillation, identified as non-sustained oversensing, due to undersensing from the device, resulted in inadequate high voltage therapy.The patient passed away.It has not yet been ruled out if the device contributed to the patient¿s death.Additional information has been requested and not yet received.

Manufacturer Narrative

Upon review, the device should not have been submitted as a medical device report (mdr) as the event did not indicate a malfunction caused a serious event.

Event Description

Additional information received indicating that the physician believes the device worked as intended based on its programmed settings during the event.The patient was at end stage heart failure and the clinic has ruled out the passing of the patient as "not unexpected".Technical support was also contacted which determined that the patient developed agonal rhythm during which resulted in undersensing.With the device's set zone configuration, nonsustained oversensing was triggered and no therapy was delivered per programmed settings.No device or lead malfunction was suspected.The event was noted when the patient was in a coronary care unit.

• Brand Name: QUADRA ASSURA MP ICD
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): ABBOTT; 645 almanor avenue; sunnyvale CA 94085
• MDR Report Key: 10759469
• MDR Text Key: 213832560
• Report Number: 2938836-2020-08983
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• PMA/PMN Number: P030054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 11/05/2020

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: 09/30/2020
• Device Model Number: CD3371-40QC
• Device Lot Number: P000068610
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/26/2020
• Initial Date FDA Received: 10/29/2020
• Supplement Dates Manufacturer Received: 10/30/2020
• Supplement Dates FDA Received: 11/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death