MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION; IMPLANTABLE LEAD

Model Number 4512

Device Problems Failure to Capture (1081); Material Integrity Problem (2978)

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

Event Date 02/16/2023

Event Type  Injury  

Event Description

It was reported that this cardiac resynchronization therapy defibrillator (crt-d) system had exhibited loss of capture on the left ventricular (lv) lead.Additionally, the right ventricular (rv) lead exhibited high pacing impedance measurements and high threshold with intermittent capture.Subsequently, a revision procedure was performed.During the explant of the device, when the device was being removed from the pocket it was noted the lv lead was fractured at the header.The device was explanted and replaced, and the lv and rv lead were surgically abandoned.The device and the broken lead will be sent back for device analysis.No additional adverse patient effects were reported.

• Brand Name: NA
• Type of Device: IMPLANTABLE LEAD
• 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: 16426587
• MDR Text Key: 310051034
• Report Number: 2124215-2023-08452
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P010012/S000
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/04/2005
• Device Model Number: 4512
• Device Catalogue Number: 4512
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/16/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/04/2003
• 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: 61 YR
• Patient Sex: Male