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

Model Number 4674

Device Problems Failure to Capture (1081); High Capture Threshold (3266)

Patient Problems Injury (2348); Heart Failure/Congestive Heart Failure (4446)

Event Date 06/05/2019

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 exhibited high thresholds and the patient reported not feeling well.Electrocardiograms confirmed loss of capture (loc).It was recommended to confirm lv lead position via x-ray.The patient was reprogrammed to right ventricular only.An echocardiogram is pending.Attempts to obtain additional information were unsuccessful.

Event Description

It was reported that this left ventricular (lv) lead exhibited high thresholds and the patient reported not feeling well.Electrocardiograms confirmed loss of capture (loc).It was recommended to confirm lv lead position via x-ray.The patient was reprogrammed to right ventricular only.An echocardiogram is pending.Attempts to obtain additional information were unsuccessful.New information received indicates that due to loss of lv therapy the patient's heart failure worsened.Surgical intervention was and the lv lead was explanted and replaced without incident.The explanted lead is not expected to be returned for evaluation.

Manufacturer Narrative

This product has not been returned for analysis.This report will be updated should additional information become available or if analysis is completed.

• Brand Name: ACUITY X4 SPIRAL S
• 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: 8759268
• MDR Text Key: 149983753
• Report Number: 2124215-2019-12822
• Device Sequence Number: 1
• Product Code: LWP
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 07/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/31/2018
• Device Model Number: 4674
• Device Catalogue Number: 4674
• Device Lot Number: 511610
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/21/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 78 YR