MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) QUARTET LEAD SMALL-S, 75 CM; PERMANENT PACEMAKER ELECTRODE

Model Number 1456Q/75

Device Problem High Capture Threshold (3266)

Patient Problem Undesired Nerve Stimulation (1980)

Event Date 07/10/2020

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 a patient's left ventricular lead exhibited high capture threshold and phrenic nerve stimulation in many vectors.Electrical parameters for the lead were normal.Lead revision procedure was done on (b)(6) 2020.The lead was explanted.While implanting a new left ventricular lead, all the positions reached exhibited high capture thresholds.A new lead was used and placed in a suitable site.No complications were reported.The patient was stable.Related manufacturer reference number: 2017865-2020-09299.

Manufacturer Narrative

The damage found was sustained during the surgical procedure.The lead was otherwise normal.

• Brand Name: QUARTET LEAD SMALL-S, 75 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: 10280596
• MDR Text Key: 199045100
• Report Number: 2017865-2020-09297
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 05414734510141
• UDI-Public: 05414734510141
• 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
• Report Date: 08/26/2020

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: 04/30/2019
• Device Model Number: 1456Q/75
• Device Catalogue Number: 1456Q/75
• Device Lot Number: S000020176
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/10/2020
• Initial Date FDA Received: 07/15/2020
• Supplement Dates Manufacturer Received: 08/21/2020
• Supplement Dates FDA Received: 08/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: QUARTET LEAD SMALL-S, 75 CM
• Patient Outcome(s): Required Intervention