MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) ABBOTT RIGHT VENTRICULAR LEAD; No Match

Model Number RV LEAD

Device Problems Signal Artifact/Noise (1036); Device Dislodged or Dislocated (2923)

Patient Problem Unspecified Infection (1930)

Event Type  Injury  

Event Description

It was reported in literature review that infection was noted.Device interrogation revealed noise and dislodgement on the right ventricular (rv) lead.The physician elected to explant the rv lead.This occurred on a multiple of rv leads and status of replacement and patient condition is unavailable.The patient condition was unknown.

Manufacturer Narrative

Correction: to h6 coding for infection instead of additional surgery.

• Brand Name: ABBOTT RIGHT VENTRICULAR LEAD
• Type of Device: No Match
• 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: 19003492
• MDR Text Key: 338901252
• Report Number: 2017865-2024-37212
• Device Sequence Number: 1
• Product Code: NVN
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RV LEAD
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/11/2024
• 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