MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ACUITY X4 SPIRAL L; IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)

Model Number 4678

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Thrombosis (2100)

Event Date 09/23/2019

Event Type  Injury  

Manufacturer Narrative

As no further information concerning this report is expected, our investigation is complete.This investigation will be updated should further information be provided.

Event Description

It was reported that this left ventricular (lv) lead was found to be dislodged during a transesophageal echocardiogram (tee).Additional information indicated that post procedure of left atrial appendage closure (laac) device, the tee showed thrombus attached to the atrial aspect of the laac device.The planned lv lead revision was cancelled and the patient was instructed to start back on medication.The lead remains in service.No adverse patient effects were reported.

Manufacturer Narrative

As no further information concerning this report is expected, our investigation is complete.This investigation will be updated should further information be provided.Upon receipt at our post market quality assurance laboratory, a visual evaluation of this lead was performed.The allegation of this lead was confirmed based on the field report and the finding of curled-up lead body which is an indication of dislodgment.

Event Description

It was reported that this left ventricular (lv) lead was found to be dislodged during a transesophageal echocardiogram (tee).Additional information indicated that post procedure of left atrial appendage closure (laac) device, the tee showed thrombus attached to the atrial aspect of the laac device.The planned lv lead revision was cancelled and the patient was instructed to start back on medication.The lead remains in service.No adverse patient effects were reported.Additional information indicated that the lead was explanted.No additional adverse patient effects were reported.

• Brand Name: ACUITY X4 SPIRAL L
• Type of Device: IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• MDR Report Key: 9623778
• MDR Text Key: 176239747
• Report Number: 2124215-2019-28577
• Device Sequence Number: 1
• Product Code: LWP
• UDI-Device Identifier: 00802526524615
• UDI-Public: 00802526524615
• 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,health
• Type of Report: Initial,Followup
• Report Date: 04/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/09/2016
• Device Model Number: 4678
• Device Catalogue Number: 4678
• Device Lot Number: 503144
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2020
• Initial Date Manufacturer Received: 10/22/2019
• Initial Date FDA Received: 01/23/2020
• Supplement Dates Manufacturer Received: 03/10/2020
• Supplement Dates FDA Received: 04/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 88 YR
• Patient Weight: 67