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

Model Number CD3371-40C

Device Problem Inappropriate or Unexpected Reset (2959)

Patient Problem Syncope (1610)

Event Date 05/08/2019

Event Type  Injury  

Manufacturer Narrative

The investigation results will be provided in the final report.

Event Description

During an emergency hospitalization, back-up mode due to power on reset (por) was observed on the device.Three aborted shocks were seen due to over-current detection (ocd), and right ventricular (rv) lead damage of a non-abbott lead is suspected to have caused the ocd.Upon entering back-up mode, the device was unable to store device memory and technical support was unable to determine if the patient received shocks.The patient reports receiving multiple shocks and experiencing a syncope.The device was replaced successfully, and the patient was stable with no adverse consequences.

Manufacturer Narrative

Additional information: the device was received in normal operating mode after being restored in the field.Bench testing was performed which included impedance measurements, sense testing, pace output testing, hv output testing, and patient notifier activation.The device tested normally in all bench testing assessments.Stress testing was performed through temperature cycling to attempt to reproduce the reported failure.After temperature cycling, bench testing was performed, which included impedance measurements and hv output testing.The device tested normally in all bench testing assessments.A device image that was retrieved prior to the device field restoration showed that cause of the reset was due to a power-on reset (por).The reported event of backup mode due to a por was confirmed.The por was unable to be reproduced and the cause of the por was undetermined.

• Brand Name: QUADRA ASSURA MP ICD
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): ABBOTT; 645 almanor avenue; sunnyvale CA 94085
• Manufacturer (Section G): ABBOTT; 645 almanor avenue; sunnyvale CA 94085
• Manufacturer Contact: elizabeth boltz ; 15900 valley view court; sylmar, CA 91342 ; 8184932577
• MDR Report Key: 8631702
• MDR Text Key: 145766449
• Report Number: 2938836-2019-03741
• 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: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/28/2020

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: 11/30/2017
• Device Model Number: CD3371-40C
• Device Lot Number: P000020251
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/08/2019
• Initial Date FDA Received: 05/22/2019
• Supplement Dates Manufacturer Received: 01/28/2020
• Supplement Dates FDA Received: 01/28/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/26/2015
• 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): Hospitalization; Required Intervention