MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RELIANCE 4-FRONT; IMPLANTABLE LEAD

Model Number 0673

Device Problems Failure to Capture (1081); Failure to Sense (1559); Low impedance (2285); Defective Device (2588)

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

Event Date 03/05/2023

Event Type  Injury  

Event Description

It was reported that this right ventricular (rv) lead exhibited pacing lead impedance (pli) measurements that were less than 200 ohms, which was out-of-range (oor).Technical services (ts) analyzed presenting electrogram (egm) and observed that there was loss of capture and no sensing of the rv lead at maximum output as well.It was noted that the patient's intrinsic rhythm was stable.Ts provided troubleshooting and recommended lead revision.It was also noted that there was a break in the insulation of this lead.Isometric testing was performed.Rv sensing was turned off and it was noted that the plan is to extract this lead.No adverse patient effects were reported.Currently, this lead remains in service.

Event Description

It was reported that this right ventricular (rv) lead exhibited pacing lead impedance (pli) measurements that were less than 200 ohms, which was out-of-range (oor).Technical services (ts) analyzed presenting electrogram (egm) and observed that there was loss of capture and no sensing of the rv lead at maximum output as well.It was noted that the patient's intrinsic rhythm was stable.Ts provided troubleshooting and recommended lead revision.It was also noted that there was a break in the insulation of this lead.Isometric testing was performed.Rv sensing was turned off and it was noted that the plan is to extract this lead.No adverse patient effects were reported.Currently, this lead remains in service.According to additional information, this lead was explanted and replaced with a new rv lead.No additional adverse patient effects were reported.This lead will not be returned to boston scientific for investigation.

• Brand Name: RELIANCE 4-FRONT
• 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: 16583715
• MDR Text Key: 311686809
• Report Number: 2124215-2023-13277
• Device Sequence Number: 1
• Product Code: LWS
• UDI-Device Identifier: 00802526592867
• UDI-Public: 00802526592867
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P910073/S145
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/23/2023

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
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/04/2024
• Device Model Number: 0673
• Device Catalogue Number: 0673
• Device Lot Number: 170812
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/06/2023
• Initial Date FDA Received: 03/21/2023
• Supplement Dates Manufacturer Received: 06/21/2023
• Supplement Dates FDA Received: 06/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/04/2022
• 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: 50 YR
• Patient Sex: Female