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

Model Number 4671

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/09/2022

Event Type  Injury  

Event Description

It was reported that this left ventricular (lv) lead has dislodged after pocket closure.The physician already exhausted all possible location and did not want to revise.The physician decided to open the pocket when the lead was back in the coronary sinus.The lead was explanted and placed a port plug.Boston scientific technical services (ts) discussed programing options when the lead is not is service.No additional adverse patient effects were reported.

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.

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.Upon receipt at our post market quality assurance laboratory, visual inspection of the lead was performed.Inspection of the lead body and electrode tip found no anomalies.Laboratory testing did not identify any lead characteristics that would have resulted in the clinical observation of dislodgement.

Event Description

It was reported that this left ventricular (lv) lead has dislodged after pocket closure.The physician already exhausted all possible location and did not want to revise.The physician decided to open the pocket when the lead was back in the coronary sinus.The lead was explanted and placed a port plug.Boston scientific technical services (ts) discussed programing options when the lead is not in service.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: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 16059304
• MDR Text Key: 306241910
• Report Number: 2124215-2022-55255
• 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: 02/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 4671
• Device Catalogue Number: 4671
• Device Lot Number: 865006
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/26/2022
• 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): Required Intervention; Hospitalization
• Patient Age: 79 YR
• Patient Sex: Female