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

Model Number 0296

Device Problems Signal Artifact/Noise (1036); Over-Sensing (1438); Pacing Problem (1439); Low impedance (2285)

Patient Problem Bradycardia (1751)

Event Date 06/19/2022

Event Type  Injury  

Event Description

It was reported that this right ventricular (rv) lead exhibited intermittent jumpy low out of range shock impedance.Additionally, there was non-physiologic artifact that is occasionally oversensed.As a result, there is pacing inhibition that lasted less than two seconds.Technical services (ts) recommended an in-office evaluation of the lead.The lead remains in use.No adverse patient effects were reported.

Event Description

It was reported that this right ventricular (rv) lead exhibited intermittent jumpy low out of range shock impedance.Additionally, there was non-physiologic artifact that is occasionally oversensed.As a result, there is pacing inhibition that lasted less than two seconds.Technical services (ts) recommended an in-office evaluation of the lead.The lead remains in use.No adverse patient effects were reported.Additional information received indicates that the lead was surgically abandoned and replaced.No additional adverse patient effects were reported.

• Brand Name: ENDOTAK RELIANCE G
• 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 55112-5798 ; 6515826168
• MDR Report Key: 18798041
• MDR Text Key: 337102794
• Report Number: 2124215-2024-11933
• Device Sequence Number: 1
• Product Code: NVY
• UDI-Device Identifier: 00802526531279
• UDI-Public: 00802526531279
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P910073/S077
• 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: 03/11/2024

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: 02/15/2020
• Device Model Number: 0296
• Device Catalogue Number: 0296
• Device Lot Number: 421917
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/16/2024
• Initial Date FDA Received: 02/28/2024
• Supplement Dates Manufacturer Received: 03/07/2024
• Supplement Dates FDA Received: 03/11/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/15/2018
• 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: 66 YR
• Patient Sex: Male