MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) QUADRA ASSURA MP ICD; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

Model Number CD3371-40QC

Device Problem Inappropriate or Unexpected Reset (2959)

Patient Problem Undesired Nerve Stimulation (1980)

Event Date 04/27/2020

Event Type  Injury  

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 patient presented with their implantable cardioverter defibrillator in backup vvi mode on (b)(6) 2020.Patient was also receiving phrenic nerve stimulation.Device was unable to be reset to original settings, so the physician explanted and replaced the device on (b)(6) 2020.Patient condition post-procedure was stable.

Manufacturer Narrative

The reported field event of a reset was confirmed in the lab.The device went to backup vvi due to a power-on-reset (por).Interrogation of the device revealed the device was above the elective replacement indicator (eri) when received.The device was tested on the bench: telemetry, pacing, sensing, impedance, hv output, hv shock and patient notifier were tested on the bench.No anomaly was detected.The reset could not be reproduced in the lab; hence the root cause of the anomaly remains undetermined.

• Brand Name: QUADRA ASSURA MP ICD
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• MDR Report Key: 10059856
• MDR Text Key: 191052099
• Report Number: 2017865-2020-06123
• 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,distri
• Type of Report: Initial,Followup,Followup
• Report Date: 12/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2020
• Device Model Number: CD3371-40QC
• Device Lot Number: A000063303
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR
• Patient Weight: 95