MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) QUARTET; PERMANENT PACEMAKER ELECTRODE

Model Number 1458Q/86

Device Problems Failure to Capture (1081); Difficult to Insert (1316); Difficult to Remove (1528); Device Dislodged or Dislocated (2923)

Patient Problem Discomfort (2330)

Event Date 12/10/2020

Event Type  Injury  

Manufacturer Narrative

This product is registered as a combination product.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 present to the clinic for a regular follow up visit.The patient was not feeling quite as good as on the last visit.Upon interrogation, there was no pacing achieved in any vector.The patient was sent for an x-ray and this confirmed the lead was dislodged.The device was programmed.The patient was stable pre, during and post visit, and will return at a later date for lead repositioning sometime next year.

Manufacturer Narrative

The damage found was sustained during the surgical procedure.Unable to perform insertion test due to the condition of lead as received.The lead was otherwise normal.

Event Description

New information notes that on (b)(6) 2021 the patient presented to the clinic for replacement of dislodged lead.During the procedure the physician attempted to advance lead back into the vein however stylet would not advance.The physician attempted to remove the lead, but it was stuck in the area of svc, the lead was cut and replaced, and the procedure was completed successfully with acceptable measurements.The patient tolerated the procedure well and was stable pre, during, and post-procedure.

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.

• Brand Name: QUARTET
• Type of Device: PERMANENT PACEMAKER ELECTRODE
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE); 645 almanor avenue; sunnyvale CA 94085
• MDR Report Key: 11074047
• MDR Text Key: 223714940
• Report Number: 2938836-2020-09836
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 05414734503198
• UDI-Public: 05414734503198
• 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,Followup
• Report Date: 03/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2022
• Device Model Number: 1458Q/86
• Device Catalogue Number: 1458Q-86
• Device Lot Number: A000086454
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention