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

Model Number 4671

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

Patient Problems Low Blood Pressure/ Hypotension (1914); Cardiac Tamponade (2226)

Event Date 11/27/2019

Event Type  Injury  

Event Description

It was reported that the physician received a remote alert regarding low pacing from the left ventricular (lv) lead.Diagnostic imaging was performed which confirmed the lead had dislodged from the original implant position.The physician attempted to reposition the lead, but the patient's anatomy was extremely difficult.Under fluoroscopy, it appeared the lead had entered the pericardial space resulting in cardiac tamponade.The patient's blood pressure dropped and additional physicians were called to stabilize the patient.The tamponade was drained and the blood pressure returned to normal.Due to tortuous patient anatomy, the physicians elected to implant a left bundle system for lv pacing to resolve the event.The patient was stable with no additional adverse consequences.

• 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; cashel road; clonmel ; EI
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 9571573
• MDR Text Key: 174402222
• Report Number: 2124215-2019-27782
• Device Sequence Number: 1
• Product Code: LWP
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P010012/S398
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/09/2020

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: 12/09/2020
• Device Model Number: 4671
• Device Catalogue Number: 4671
• Device Lot Number: 815484
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/27/2019
• Initial Date FDA Received: 01/09/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/09/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 65 YR