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

Model Number 4674

Device Problem Difficult to Insert (1316)

Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/18/2020

Event Type  malfunction  

Event Description

It was reported that during the implant procedure, the physician experienced difficulty when attempting to flush this left ventricular (lv) lead because the lead lumen appeared to be closed.A wire was inserted, however, the physician was not able to insert the wire beyond a few centimeters.The physician elected to exchange this lv lead to resolve the event.The patient was stable with no adverse consequences.The lead is expected or analysis, but has not yet been received.

Event Description

It was reported that during the implant procedure, the physician experienced difficulty when attempting to flush this left ventricular (lv) lead because the lead lumen appeared to be closed.A wire was inserted, however, the physician was not able to insert the wire beyond a few centimeters.The physician elected to exchange this lv lead to resolve the event.The patient was stable with no adverse consequences.The lead was discarded and will not be returned for analysis.

Manufacturer Narrative

With all the available information, bsc is unable to conclude the root cause of the incident.This device has not been returned; therefore, a technical analysis cannot be conducted.Without a returned device it is not possible to definitively confirm how the device may have contributed to the complaint incident.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 S
• 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: 11233963
• MDR Text Key: 228845266
• Report Number: 2124215-2020-29132
• Device Sequence Number: 1
• Product Code: LWP
• Combination Product (y/n): N
• 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

• Date FDA Received: 01/26/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/09/2022
• Device Model Number: 4674
• Device Catalogue Number: 4674
• Device Lot Number: 846734
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/07/2021
• Patient Sequence Number: 1
• Patient Age: 68 YR