MAUDE Adverse Event Report: SORIN BIOMEDICAL INC RV LEAD; DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER

Model Number 2CR6

Device Problems Pacing Problem (1439); Appropriate Term/Code Not Available (3191)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

It was reported that this right ventricular (rv) lead pacing threshold increased.The lead is part of an advisory, therefore, the decision was made to explant and replace this rv lead.This lead was successfully replaced.No additional adverse patient effects were reported.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: RV LEAD
• Type of Device: DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
• Manufacturer (Section D): SORIN BIOMEDICAL INC
• MDR Report Key: 17524904
• MDR Text Key: 321312293
• Report Number: MW5131846
• Device Sequence Number: 1
• Product Code: MRM
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Model Number: 2CR6
• Patient Sequence Number: 1