MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ENDOTAK RELIANCE S; IMPLANTABLE LEAD

Model Number 0138

Device Problems Fracture (1260); High impedance (1291); Failure to Sense (1559)

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

Event Date 07/21/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that during implant procedure, this right ventricular (rv) lead exhibited intermittent capture and high out of range (oor) pacing impedance measurements.Physician took this lead out and cleaned it and put it back in but the same oor measurements continued.A lead fracture was suspected to be the cause of this oor measurements.This rv lead was then successfully replaced by a non boston scientific lead.No adverse patient effects were reported.Lead is expected to be return.

Event Description

It was reported that during implant procedure, this right ventricular (rv) lead exhibited intermittent capture and high out of range (oor) pacing impedance measurements.Physician took this lead out and cleaned it and put it back in but the same oor measurements continued.A lead fracture was suspected to be the cause of this oor measurements.This rv lead was then successfully replaced by a non boston scientific lead.No adverse patient effects were reported.Lead was returned for analysis.

Manufacturer Narrative

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

• Brand Name: ENDOTAK RELIANCE S
• 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: 12620416
• MDR Text Key: 276208094
• Report Number: 2124215-2021-29116
• Device Sequence Number: 1
• Product Code: LWS
• Combination Product (y/n): Y
• Reporter Country Code: EI
• PMA/PMN Number: P910073/S039
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/05/2022

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
• Device Operator: Health Professional
• Device Expiration Date: 11/25/2022
• Device Model Number: 0138
• Device Catalogue Number: 0138
• Device Lot Number: 302481
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/23/2021
• Initial Date FDA Received: 10/12/2021
• Supplement Dates Manufacturer Received: 02/02/2022
• Supplement Dates FDA Received: 04/05/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/25/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention