MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) ABBOTT LEFT VENTRICULAR LEAD; Drug eluting permanent left ventricular (lv) pacemaker electrode

Model Number LV LEAD

Device Problems High impedance (1291); Device Dislodged or Dislocated (2923)

Patient Problem Perforation of Vessels (2135)

Event Date 07/13/2023

Event Type  Injury  

Manufacturer Narrative

Sus voluntary event report was received.Medwatch: mw5120738.

Event Description

It was reported via voluntary medwatch that the patient presented in clinic for left ventricular (lv) lead revision due to high pacing impedance.During revision, the lv lead was dislodged and punctured the subclavian vein.The lv lead was explanted and replaced.Further information was not provided.

• Brand Name: ABBOTT LEFT VENTRICULAR LEAD
• Type of Device: Drug eluting permanent left ventricular (lv) 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: 17770382
• MDR Text Key: 323679264
• Report Number: 2017865-2023-45401
• Device Sequence Number: 1
• Product Code: OJX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: LV LEAD
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention