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

Model Number 4674

Device Problems Device Dislodged or Dislocated (2923); Positioning Problem (3009)

Patient Problem Device Overstimulation of Tissue (1991)

Event Date 02/09/2024

Event Type  Injury  

Event Description

It was reported that the current implanted device was being upgraded to a cardiac resynchronization therapy defibrillator (crt-d).During wound closure phrenic nerve stimulation was observed on this attempted left ventricular (lv) lead.Fluoroscopy was performed and showed the lv lead had pulled back from the vein.The physician attempted to reposition the lead and was unsuccessful.The physician elected to use a non-boston scientific lead to complete the procedure.The cardiac resynchronization therapy defibrillator (crt-d) was also changed out to accommodate the new lead.The attempted lead and exchanged device will not be returned for analysis.No adverse patient effects were reported.

• 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
• 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: 18773251
• MDR Text Key: 336176185
• Report Number: 2124215-2024-10977
• Device Sequence Number: 1
• Product Code: LWP
• Combination Product (y/n): Y
• Reporter Country Code: AS
• PMA/PMN Number: P010012/S398
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 4674
• Device Catalogue Number: 4674
• Device Lot Number: 889453
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/09/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/16/2022
• 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: 60 YR