MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION FINELINE II STEROX; IMPLANTABLE LEAD

Model Number 4480

Device Problems Failure to Capture (1081); Pacing Problem (1439); Device Dislodged or Dislocated (2923)

Patient Problem Twiddlers Syndrome (4563)

Event Date 04/01/2024

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that this right atrial (ra) lead exhibited pacing failure and loss of capture.This lead had fallen off due to twiddler's syndrome, and the lead was dislodged.This lead was surgically abandoned, and a new lead was successfully implanted.No additional adverse patient effects were reported.

• Brand Name: FINELINE II STEROX
• 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; cashel road; clonmel ; EI
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 19198040
• MDR Text Key: 341235986
• Report Number: 2124215-2024-25495
• Device Sequence Number: 1
• Product Code: DTB
• Combination Product (y/n): Y
• Reporter Country Code: JA
• PMA/PMN Number: P960004/S014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/20/2014
• Device Model Number: 4480
• Device Catalogue Number: 4480
• Device Lot Number: 593059
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/01/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/20/2012
• 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): Required Intervention; Hospitalization
• Patient Age: 97 YR
• Patient Sex: Male