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

Model Number CD3371-40QC

Device Problems High impedance (1291); Loose or Intermittent Connection (1371); Over-Sensing (1438); Failure to Disconnect (2541); Connection Problem (2900)

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

Event Date 05/04/2021

Event Type  Injury  

Manufacturer Narrative

Further information was requested but not received.

Event Description

Related manufacturer report number 2017865-2021-18211.During a remote follow up, high pacing impedance and noise resulting in oversensing were noted on the right ventricular (rv) lead.X-ray imaging was performed and it was suspected that the rv lead was not properly connected to the device header.No intervention has been performed.The patient was in stable condition.

Event Description

Additional information indicates during revision the set screw was difficult to loosen and tighten.The device was explanted and replaced to resolve the event.

Manufacturer Narrative

The reported events of sensing noise, high impedance and lead connection issue could not be confirmed.The set screws operated normally in affixing the test leads to the header; no anomalies was detected.Telemetry, impedance, sensing, pacing and high voltage (hv) output functions of the device were tested and found to be normal.

• 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: sonali arangil ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 11848703
• MDR Text Key: 251413251
• Report Number: 2017865-2021-18210
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 01/31/2022

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: 05/31/2021
• Device Model Number: CD3371-40QC
• Device Lot Number: P000081327
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/05/2021
• Initial Date FDA Received: 05/19/2021
• Supplement Dates Manufacturer Received: 05/28/2021; 06/15/2021; 09/23/2021; 01/21/2022
• Supplement Dates FDA Received: 06/11/2021; 06/18/2021; 09/23/2021; 01/31/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/13/2019
• 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; DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR
• Patient Outcome(s): Required Intervention