MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) QUARTET LEAD SMALL-S, 86 CM; PERMANENT PACEMAKER ELECTRODE

Model Number 1456Q/86

Device Problems Failure to Capture (1081); Device Dislodged or Dislocated (2923)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/31/2020

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 asymptomatic patient presented in clinic for a follow up.Upon examination, it was discovered that the left ventricular lead exhibited loss of capture on all poles of the lead.An x-ray taken in august 2020 was reviewed and it was determined that the lead had dislodged.The dislodgement was not noticed by the radiologist at the time.The left ventricular lead was then programmed off until a lead revision can be performed.The patient's condition was stable.

Event Description

New information received stated that on (b)(6) 2021, the left ventricular lead was explanted and replaced.The patient's condition was stable before, during, and after the procedure.

Manufacturer Narrative

Analysis was normal.No anomalies were found.

Manufacturer Narrative

Correction h1 type of reportable event should be serious injury instead than malfunction.Correction h6 type of investigation should be testing of actual or suspected device instead of device not returned.

• Brand Name: QUARTET LEAD SMALL-S, 86 CM
• Type of Device: PERMANENT PACEMAKER ELECTRODE
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• MDR Report Key: 11181434
• MDR Text Key: 227563539
• Report Number: 2017865-2021-02235
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 05414734510158
• UDI-Public: 05414734510158
• 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,health
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/08/2021

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: 08/31/2022
• Device Model Number: 1456Q/86
• Device Catalogue Number: 1456Q/86
• Device Lot Number: A000086269
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/05/2021
• Initial Date FDA Received: 01/15/2021
• Supplement Dates Manufacturer Received: 01/27/2021; 03/02/2021; 03/08/2021
• Supplement Dates FDA Received: 02/17/2021; 03/03/2021; 03/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 79 YR