MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ACUITY X4 SPIRAL S; IMPLANTABLE LEAD

Model Number 4674

Device Problems Pacing Problem (1439); Device Dislodged or Dislocated (2923)

Patient Problems Chest Pain (1776); Dizziness (2194); Heart Failure (2206); Stenosis (2263)

Event Date 05/17/2019

Event Type  Injury  

Manufacturer Narrative

At this time, the lead has not been returned for evaluation.This record will be updated upon return and completion of evaluation or if additional information becomes available.

Event Description

It was reported that this patient presented to the emergency room due to dizziness and chest pain.It was determined that this left ventricular (lv) lead had dislodged.This resulted in loss of biventricular pacing and exacerbation of the patient's heart failure symptoms.A revision procedure was performed wherein this lv lead was explanted and replaced.It was noted that the vessel where this lead had originally been placed was occluded, so the physician elected to place a new lead rather than attempting to reposition this one.No additional adverse patient effects were reported.

Event Description

This report is being filed as the lead was returned and evaluation was completed.

Manufacturer Narrative

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.Testing was completed to assess lead electrical performance and inner/outer insulation integrity.Measurements throughout these tests were within normal limits.Laboratory testing was unable to reproduce the reported clinical observations and detailed analysis did not reveal any abnormalities.Laboratory analysis did not identify any lead characteristics that would have caused or contributed to the reported clinically observed pacing issues.

• Brand Name: ACUITY X4 SPIRAL S
• Type of Device: IMPLANTABLE LEAD
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• MDR Report Key: 8848156
• MDR Text Key: 152853246
• Report Number: 2124215-2019-14830
• Device Sequence Number: 1
• Product Code: LWP
• UDI-Device Identifier: 00802526524554
• UDI-Public: 00802526524554
• Combination Product (y/n): N
• PMA/PMN Number: P010012/S398
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,study
• Type of Report: Initial,Followup
• Report Date: 10/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/13/2021
• Device Model Number: 4674
• Device Catalogue Number: 4674
• Device Lot Number: 822595
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2019
• Date Manufacturer Received: 10/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 53 YR
• Patient Weight: 91