MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ACUITY X4 SPIRAL L; IMPLANTABLE LEAD

Model Number 4677

Device Problems Failure to Capture (1081); Device Sensing Problem (2917); Device Contamination with Chemical or Other Material (2944)

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

Event Date 10/04/2022

Event Type  Injury  

Event Description

It was reported that during a revision procedure when they took the left ventricular (lv) lead out there was blood in the insulation.A new lead was used, and they wiped it off and there is still blood within the insulation.Additionally, there were observations of loss of capture and sensing.Technical services recommended to use a different lead and to return it for device analysis.Attempts were made to the field representative for additional information however, no new information was obtained.No additional adverse patient effects were reported.

• Brand Name: ACUITY X4 SPIRAL L
• Type of Device: IMPLANTABLE LEAD
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• Manufacturer (Section G): BOSTON SCIENTIFIC
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 15714094
• MDR Text Key: 302838535
• Report Number: 2124215-2022-44925
• Device Sequence Number: 1
• Product Code: LWP
• 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: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 4677
• Device Catalogue Number: 4677
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization