MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION FLEXTEND; PERMANENT PACEMAKER ELECTRODE

Model Number 4088

Device Problems High impedance (1291); Connection Problem (2900)

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

Event Date 12/01/2023

Event Type  Injury  

Event Description

It was reported that this right ventricular (rv) lead exhibited a high out-of-range pace impedance measurement.It was noted that the patient underwent a recent device changeout in october.This rv lead remains in service, however lead revision was anticipated.No adverse patient effects were reported.

Manufacturer Narrative

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

Event Description

It was reported that this right ventricular (rv) lead exhibited a high out-of-range pace impedance measurement.It was noted that the patient underwent a recent device changeout in october.This rv lead remains in service, however lead revision was anticipated.No adverse patient effects were reported.Additional information received reported that this right ventricular (rv) lead was not fully inserted into the new device header at the october device changeout procedure.The patient underwent a lead revision and upon opening the device pocket, the physician noted that the lead was easily pulled from the device header.The lead was properly re-inserted into the device header, and the patient was discharged home.This rv lead remains in service.No additional adverse patient effects were reported.

Manufacturer Narrative

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

• Brand Name: FLEXTEND
• Type of Device: PERMANENT PACEMAKER ELECTRODE
• 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: 18622745
• MDR Text Key: 334388741
• Report Number: 2124215-2024-05600
• Device Sequence Number: 1
• Product Code: DTB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P960006/S005
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/03/2015
• Device Model Number: 4088
• Device Catalogue Number: 4088
• Device Lot Number: 242711
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/01/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/03/2013
• 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: 72 YR
• Patient Sex: Male