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

Model Number 0673

Device Problems Pocket Stimulation (1463); Device Dislodged or Dislocated (2923)

Patient Problems Muscle Stimulation (1412); No Consequences Or Impact To Patient (2199); No Code Available (3191)

Event Date 12/18/2019

Event Type  Injury  

Manufacturer Narrative

The lead is expected to be returned for analysis.This report will be updated upon completion of investigation.

Event Description

It was reported during ongoing use, the ventricle lead was dislocated, and causing diaphragmatic stimulation.The lead was explanted and replaced.There was no harm to the patient, and it was also indicated that the patient did not receive any inappropriate therapy.The patient is also not pacemaker dependent.The new lead showed good sensing values, and the old lead will be returned for analysis.

Event Description

It was reported during ongoing use, the (rv) right ventricle lead was dislocated, and causing diaphragmatic stimulation.Therefore, the lead was explanted and replaced.The new rv lead showed normal sensing values.There was no harm to the patient, and it was also reported that the patient did not receive any inappropriate therapy.Additionally, it was indicated that the patient is not pacemaker dependent.

Manufacturer Narrative

Upon receipt at our post market quality assurance laboratory, the lead was received with the helix in an extended position.Visual inspection revealed no abnormalities, as the lead tip/helix appeared normal.A thorough evaluation of the lead was performed.Testing was completed to assess lead electrical performance and inner/outer insulation integrity.Measurements throughout these tests were within normal limits.Microscopic inspections of the terminal pin assembly, lead body, and electrode tip found no anomalies.Laboratory analysis did not identify any lead characteristics that would have caused or contributed to the reported clinical observations.Laboratory observations and the field report were insufficient to verify dislodgment.The allegation of muscle stimulation is a known inherent risk of the device, which likely occurred due to the dislodgment.The surgery allegation could not be confirmed, as there was no evidence of device damage, defect, or malfunction found.Patient code (b)(4) captures the reportable event of surgery.

• 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: 9550672
• MDR Text Key: 173694818
• Report Number: 2124215-2019-27289
• 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: 04/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/03/2021
• Device Model Number: 0673
• Device Catalogue Number: 0673
• Device Lot Number: 107510
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2020
• Date Manufacturer Received: 03/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 84 YR