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

Model Number	0137
Medical Device Problem Codes	Signal Artifact/Noise (1036); Off-Label Use (1494)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/06/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during the system change procedure, the physician opted to place this right ventricular (rv) lead outside of the heart.The rv lead tip was capped and sewn down; however noisy signals were seen through the new implanted device.Technical services (ts) stated that if the rv was to be sewn on the outside of the heart it will not be going to sense ventricular fibrillation (vf) appropriately.It was at physician's discretion to proceed.This rv remains in service.No additional patient adverse effects were reported.
Additional Manufacturer Narrative
Correction to field h6: impact codes.
Event or Problem Description
It was reported that during the system change procedure, the physician opted to place this right ventricular (rv) lead outside of the heart.The rv lead tip was capped and sewn down; however noisy signals were seen through the new implanted device.Technical services (ts) stated that if the rv was to be sewn on the outside of the heart it will not be going to sense ventricular fibrillation (vf) appropriately.It was at physician's discretion to proceed.This rv remains in service.No additional patient adverse effects were reported.

• Brand Name: ENDOTAK RELIANCE S
• Common Device Name: 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: 18314159
• Report Number: 2124215-2023-70528
• Device Sequence Number: 6115408
• Product Code: LWS
• UDI-Device Identifier: 00802526531101
• UDI-Public: 00802526531101
• Combination Product (Y/N): Y
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: P910073/S039
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/10/2024

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 01/30/2025
• Device Model Number: 0137
• Device Catalogue Number: 0137
• Device Lot Number: 301456
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/06/2023
• Supplement Date Received by Manufacturer: 01/03/2024
• Initial Report FDA Received Date: 12/12/2023
• Supplement Report FDA Received Date: 01/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/30/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 69 YR
• Patient Sex: Unknown