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

Model Number 1456Q/86

Device Problems Difficult to Insert (1316); Capturing Problem (2891); Device Dislodged or Dislocated (2923)

Patient Problem Muscle Stimulation (1412)

Event Date 07/07/2020

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 presented for follow-up with diaphragmatic stimulation.Upon interrogation lead threshold was not found, and fluoroscopy revealed the lead had dislodged.During the lead repositioning procedure, it was difficult to insert the style into the lead.The lead was explanted and replaced.The patient was stable.

Manufacturer Narrative

The reported events were lead dislodgment, failure to capture and ¿not able to manage stylet into the lead¿.As received, a complete lead was returned in one piece for analysis.The reported event of failure to capture was not confirmed.Electrical testing did not find any indication of conductor fractures or internal shorts.The reported event of ¿not able to manage stylet into the lead¿ was confirmed.Visual inspection of the lead found the inner coil to be bunched up as well as ptfe coating of stylet was found stripped off/bunched up/clogged inside the inner coil.S-curve height was measured to be within specification.The reported event of ¿not able to manage stylet into the lead¿ was isolated to the ptfe coating clogged inside the inner coil.

• Brand Name: QUARTET LEAD SMALL-S, 86 CM
• Type of Device: PERMANENT PACEMAKER ELECTRODE
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE); 645 almanor avenue; sunnyvale CA 94085
• MDR Report Key: 10317713
• MDR Text Key: 200199857
• Report Number: 2938836-2020-07601
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 01/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2022
• Device Model Number: 1456Q/86
• Device Catalogue Number: 1456Q/86
• Device Lot Number: A000090918
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR
• Patient Weight: 60