MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RELIANCE 4-FRONT; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)

Model Number 0672

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

Patient Problems Muscle Stimulation (1412); Device Overstimulation of Tissue (1991); No Code Available (3191)

Event Date 10/23/2020

Event Type  Injury  

Manufacturer Narrative

The product has been received for analysis.This report will be updated upon completion of analysis.(b)(4).

Event Description

It was reported that this right ventricular (rv) lead was explanted and replaced due to dislodgement.Dislodgement was discovered via x-ray.Patient experienced post-implant nerve phrenic stimulation as the lead was placed in the coronary sinus.During surgical procedure the physician could not reposition the lead as it was unable to advance stylet to the tip of the lead; therefore, decided to replace it instead.No additional adverse patient effects were reported.

Manufacturer Narrative

Supplemental: upon receipt at our post market quality assurance laboratory, visual inspection of the lead was performed.Inspection of the lead body and electrode tip found no anomalies.Laboratory testing did not identify any lead characteristics that would have resulted in the clinical observation of dislodgement.Initial: the product has been received for analysis.This report will be updated upon completion of analysis.Patient code 3191 captures the reportable event of surgery.

Event Description

It was reported that this right ventricular (rv) lead was explanted and replaced due to dislodgement.Dislodgement was discovered via x-ray.Patient experienced post-implant nerve phrenic stimulation as the lead was placed in the coronary sinus.During surgical procedure the physician could not reposition the lead as it was unable to advance stylet to the tip of the lead; therefore, decided to replace it instead.This lead was returned for analysis.No additional adverse patient effects were reported.

• Brand Name: RELIANCE 4-FRONT
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• MDR Report Key: 11201242
• MDR Text Key: 227745956
• Report Number: 2124215-2020-28541
• Device Sequence Number: 1
• Product Code: LWS
• Combination Product (y/n): N
• 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: 08/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/21/2022
• Device Model Number: 0672
• Device Catalogue Number: 0672
• Device Lot Number: 137436
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2020
• Date Manufacturer Received: 04/28/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention