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

Model Number 4671

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Erosion (1750); Unspecified Infection (1930); Pain (1994)

Event Date 01/15/2024

Event Type  Injury  

Event Description

It was reported that this left ventricular (lv) lead was part of a system revision due to lead erosion.The patient was already checked by the physician and was informed that it was normal and fine.However, the patient did not believe and was concerned about the status of the device.There were no additional adverse patient effects reported.This lv lead remains in service.

Manufacturer Narrative

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

Manufacturer Narrative

This supplemental report was created to update h6: patient codes with pain.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that this left ventricular (lv) lead was part of a system revision due to lead erosion.The patient was already checked by the physician and was informed that it was normal and fine.However, the patient did not believe and was concerned about the status of the device.There were no additional adverse patient effects reported.This lv lead remains in service.Additional information indicated that the device was not in the pouch and that one of the leads was sticking up, which made the patient feel worse.The technical services (ts) advised it was not typical to have leads protruding and the skin was whitening.Additionally, the patient's right side of the neck was painful.

• 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: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 19149622
• MDR Text Key: 340673157
• Report Number: 2124215-2024-24104
• 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: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/27/2024

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?: No
• Device Operator: Lay User/Patient
• Device Model Number: 4671
• Device Catalogue Number: 4671
• Device Lot Number: 881956
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/19/2024
• Supplement Dates Manufacturer Received: 05/22/2024
• Supplement Dates FDA Received: 05/27/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/18/2023
• 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): Required Intervention; Hospitalization
• Patient Age: 67 YR
• Patient Sex: Male