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

Model Number 4675

Device Problem High impedance (1291)

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

Event Date 12/02/2022

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the system with this left ventricular (lv) lead and a cardiac resynchronization therapy pacemaker (crt-p), showed a high, out of range (oor) pacing impedances alert short after being implanted.The impedance value was high and went oor at implant procedure.The lv lead and the crt-p remain in service.It was recommended to reprogram the oor limit for the device.No procedure was recommended.No adverse patient effects were reported.

• Brand Name: ACUITY X4 SPIRAL S
• Type of Device: IMPLANTABLE LEAD
• 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: 16046668
• MDR Text Key: 307990003
• Report Number: 2124215-2022-54903
• 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: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 4675
• Device Catalogue Number: 4675
• Device Lot Number: 824127
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/05/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2022
• 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 Age: 63 YR
• Patient Sex: Male