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

Model Number 4671

Device Problem Pocket Stimulation (1463)

Patient Problem Device Overstimulation of Tissue (1991)

Event Date 07/05/2022

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the patient with this left ventricular (lv) lead experienced phrenic nerve stimulation.The lead was surgically explanted and replaced.No additional adverse patient effects were reported.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.Upon receipt at our post market quality assurance laboratory, a thorough evaluation of the left ventricular (lv) 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 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 clinical observations.

Event Description

It was reported that the patient with this left ventricular (lv) lead experienced phrenic nerve stimulation.The lead was surgically explanted and replaced.No additional adverse patient effects were reported.

• 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
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; road 698, lot no. 12; dorado PR 00646 -260; * 00646-2602
• Manufacturer Contact: timoth degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 15070389
• MDR Text Key: 296286067
• Report Number: 2124215-2022-26657
• Device Sequence Number: 1
• Product Code: LWP
• UDI-Device Identifier: 00802526524516
• UDI-Public: 00802526524516
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P010012/S398
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/30/2024
• Device Model Number: 4671
• Device Catalogue Number: 4671
• Device Lot Number: 857325
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/11/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/11/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/30/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 52 YR
• Patient Sex: Female