MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION FINELINE II STEROX; PERMANENT PACEMAKER ELECTRODE

Model Number	4459
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	Bradycardia (1751)
Date of Event	03/13/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that this right ventricular (rv) lead's insulation was damaged.During generator change, this rv lead was noted to have lost its insulation.Moreover, the patient also experienced bradycardia.This rv lead was surgically abandoned and replaced.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.Upon receipt at our post market quality assurance laboratory, a thorough analysis was performed with the lead.The returned lead was severed approximately 90 millimeters from the terminal end and only the proximal segment was returned.Moreover, analysis confirmed insulation damage where the insulation was cut approximately 50 millimeters from the terminal pin.The insulation was torn around the circumference at this location.Furthermore, it was concluded that this is an unintended use error based on the analysis finding of induced damage.The observed damage is not deemed to indicate a product defect or malfunction.
Event or Problem Description
It was reported that this right ventricular (rv) lead's insulation was damaged.During generator change, this rv lead was noted to have lost its insulation.Moreover, the patient also experienced bradycardia.This rv lead was surgically abandoned and replaced.No additional adverse patient effects were reported.Additional information indicated that this lead was explanted.

• Brand Name: FINELINE II STEROX
• Common Device Name: PERMANENT PACEMAKER ELECTRODE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• Manufacturer (Section G): CPI - DEL CARIBE; guidant puerto rico b. v.; #12, rd. #698; dorado PR 00646
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 16592333
• Report Number: 2124215-2023-13543
• Device Sequence Number: 16852627
• Product Code: DTB
• UDI-Device Identifier: 00802526061004
• UDI-Public: 00802526061004
• Combination Product (Y/N): Y
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P960004/S014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2004
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 04/01/2005
• Device Model Number: 4459
• Device Catalogue Number: 4459
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/13/2023
• Supplement Date Received by Manufacturer: 07/12/2023
• Initial Report FDA Received Date: 03/22/2023
• Supplement Report FDA Received Date: 08/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/01/2003
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Male