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

Model Number 4671

Device Problems Failure to Capture (1081); Fracture (1260); Use of Device Problem (1670)

Patient Problems No Code Available (3191); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/23/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that during a routine follow-up, device interrogation showed intermittent capture at maximum output on the left ventricular (lv) channel.The physician elected to explant the lv lead and did left bundle ranch pacing.During the intervention procedure, the physician inspected the lead and suspected lead fracture due to the patient previously underwent a cardiac angioplasty procedure.No additional adverse patient effects were reported.

Event Description

It was reported that during a routine follow-up, device interrogation showed intermittent capture at maximum output on the left ventricular (lv) channel.The physician elected to explant the lv lead and did left bundle ranch pacing.During the intervention procedure, the physician inspected the lead and suspected lead fracture due to the patient previously underwent a cardiac angioplasty procedure.No additional adverse patient effects were reported.

Manufacturer Narrative

The device is not expected to be returned; therefore, technical analysis cannot be conducted.Without a returned device it is not possible to definitively confirm how the device may have contributed to the complaint incident.If information is provided in the future, a supplemental report will be issued.

• Brand Name: ACUITY X4 STRAIGHT
• 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: 11234057
• MDR Text Key: 228837368
• Report Number: 2124215-2020-29184
• 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: 02/21/2021

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: 09/22/2021
• Device Model Number: 4671
• Device Catalogue Number: 4671
• Device Lot Number: 826082
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/23/2020
• Initial Date FDA Received: 01/26/2021
• Supplement Dates Manufacturer Received: 01/25/2021
• Supplement Dates FDA Received: 02/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention