MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) QUICKFLEX MICRO LV LEAD; PERMANENT PACEMAKER ELECTRODE

Model Number 1258T/86

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems No Consequences Or Impact To Patient (2199); No Information (3190); No Clinical Signs, Symptoms or Conditions (4582)

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

Related manufacturer reference number: 2017865-2020-16085.It was reported the left ventricular lead was capped on (b)(6) 2020 due to lead dislodgement and the implantable cardioverter was also explanted for unknown reasons.How the issue was discovered was unknown.The patient symptoms and current condition were unknown.

Manufacturer Narrative

Additional information: a4, b5, b6, h6.Correction: d11 ( no concomitant devices ).

Event Description

New information revealed the asymptomatic patient had an chest x-ray completed to confirm the dislodgement prior to procedure.The patient was stable.

Event Description

New information received indicated the left ventricular lead was explanted on (b)(4) 2024.No replacement left ventricular lead was placed.

Manufacturer Narrative

The lead was returned due to the reported event of lead dislodgement.As received, a partial lead was returned in two pieces.Electrical testing did not find any indication of conductor fractures or internal shorts.Visual inspection of the lead did not find any anomalies except for procedural damages.The s-curve hump height was measured within specification.

• Brand Name: QUICKFLEX MICRO LV LEAD
• Type of Device: PERMANENT PACEMAKER ELECTRODE
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: richard williamson ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 10731311
• MDR Text Key: 212965864
• Report Number: 2017865-2020-16083
• Device Sequence Number: 1
• Product Code: OJX
• UDI-Device Identifier: 05414734502610
• UDI-Public: 05414734502610
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2015
• Device Model Number: 1258T/86
• Device Catalogue Number: 1258T-86
• Device Lot Number: 3721244
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/02/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/06/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNIFY ASSURA CRT-D RF HV
• Patient Outcome(s): Required Intervention
• Patient Age: 82 YR
• Patient Sex: Female
• Patient Weight: 91 KG