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

Model Number CD3387-40QC

Device Problems Loose or Intermittent Connection (1371); Failure to Disconnect (2541)

Patient Problem Discomfort (2330)

Event Date 03/08/2021

Event Type  malfunction  

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 the patient presented for a device implant procedure on (b)(6) 2021.During the procedure, the set screw could not be turned with the torque wrench.Additionally, the torque wrench got stuck in the header.The patient complained of discomfort at the pocket.The device was removed and replace.The patient had no adverse consequences.

Manufacturer Narrative

The reported field event of a screw anomaly was not confirmed in the laboratory.The device was tested on the bench and no anomalies were found.

Manufacturer Narrative

Correction: b3 event date should be mar 8, 2021.

Manufacturer Narrative

The reported event of set screw anomaly could not be confirmed in the lab.The device was tested on the bench [and using automated testing equipment,] and no anomalies were found.

• Brand Name: QUADRA + EXCELIS 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: 11579781
• MDR Text Key: 242685640
• Report Number: 2017865-2021-13031
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2022
• Device Model Number: CD3387-40QC
• Device Lot Number: P000098542
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/08/2021
• Initial Date FDA Received: 03/27/2021
• Supplement Dates Manufacturer Received: 04/14/2021; 05/09/2021; 05/24/2021
• Supplement Dates FDA Received: 05/05/2021; 05/10/2021; 06/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1