MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION; IMPLANTABLE LEAD

Model Number 4054

Device Problems Fracture (1260); Off-Label Use (1494); Difficult to Remove (1528); Low impedance (2285); Connection Problem (2900)

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

Event Date 10/24/2022

Event Type  Injury  

Event Description

It was reported that this right atrial (ra) lead became stuck in the device header during scheduled generator change procedure.Technical services (ts) was contacted and provided troubleshooting.Physician utilized a lead repair kit which is considered to be off-label use.The ra lead was held in place and procedure was completed.Post-procedure lead testing measurements were within normal limits.It was noted that the pacing impedance was low but within normal limits.System extraction will be performed at a later date to rectify because patient does require pacing in the ra.No additional adverse patient effects were reported outside of prolonged procedure.Currently, this lead remains in service.

Event Description

It was reported that this right atrial (ra) lead became stuck in the device header during scheduled generator change procedure.Technical services (ts) was contacted and provided troubleshooting.Physician utilized a lead repair kit which is considered to be off-label use.The ra lead was held in place and procedure was completed.Post-procedure lead testing measurements were within normal limits.It was noted that the pacing impedance was low but within normal limits.System extraction will be performed at a later date to rectify because patient does require pacing in the ra.No additional adverse patient effects were reported outside of prolonged procedure.Currently, this lead remains in service.According to additional information received, this ra lead was explanted due to a break or fracture in the lead, variations in impedance measurements, and disconnection with implanted device.Another ra lead was successfully placed.No additional adverse patient effects were reported.

• 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: 15698301
• MDR Text Key: 302678248
• Report Number: 2124215-2022-44390
• Device Sequence Number: 1
• Product Code: DTB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P960006/S001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/27/2007
• Device Model Number: 4054
• Device Catalogue Number: 4054
• Device Lot Number: 449253
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/03/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/27/2005
• 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 Outcome(s): Hospitalization; Required Intervention
• Patient Age: 38 YR
• Patient Sex: Female