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

Model Number 4677

Device Problems Failure to Capture (1081); Device Dislodged or Dislocated (2923); Human-Device Interface Problem (2949); High Capture Threshold (3266)

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

Event Date 02/23/2021

Event Type  Injury  

Event Description

It was reported that a dislodgment occurred with this left ventricular (lv) lead post procedure, resulting in loss of capture, and high capture thresholds.It was noted that the procedure was prolonged due to coronary sinus cannulation.The lead was initially inserted with use of an acuity pro catheter, and was successfully positioned in the targeted vein, with satisfactory capture prior to slitting the catheter.The lead had pulled back slightly when attempting to slit the catheter; however, the lead was repositioned prior to cutting the catheter away, and showed successful lead parameters.It was during the post-op check that loss of capture, and high capture thresholds were observed.An x-ray was taken, confirming the dislodgement.The patient was discharged, and a revision procedure is anticipated, but has not yet been performed.No additional adverse patient effects were reported.

Event Description

It was reported that a dislodgment occurred with this left ventricular (lv) lead post procedure, resulting in loss of capture, and high capture thresholds.It was noted that the procedure was prolonged due to coronary sinus cannulation.The lead was initially inserted with use of an acuity pro catheter, and was successfully positioned in the targeted vein, with satisfactory capture prior to slitting the catheter.The lead had pulled back slightly when attempting to slit the catheter; however, the lead was repositioned prior to cutting the catheter away, which showed successful lead parameters.It was during the post-op check that loss of capture, and the high capture thresholds were observed.An x-ray was taken, confirming the dislodgement.Subsequently, this lead was explanted and replaced for a competitor's lead.No additional adverse patient effects were reported.This lead is not available for return.

Manufacturer Narrative

As no further information concerning this report is expected, our investigation is complete.This investigation will be updated should further information be provided.

• Brand Name: ACUITY X4 SPIRAL L
• Type of Device: IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• MDR Report Key: 11382883
• MDR Text Key: 233718528
• Report Number: 2124215-2021-04550
• Device Sequence Number: 1
• Product Code: LWP
• Combination Product (y/n): Y
• PMA/PMN Number: P010012/S398
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 04/07/2021

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: 01/11/2023
• Device Model Number: 4677
• Device Catalogue Number: 4677
• Device Lot Number: 820830
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/23/2021
• Initial Date FDA Received: 02/25/2021
• Supplement Dates Manufacturer Received: 03/19/2021
• Supplement Dates FDA Received: 04/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 67 YR