MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ENDOTAK RELIANCE SG; Implantable lead

Model Number	0292
Medical Device Problem Code	Data Problem (3196)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/04/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the health care professional (hcp) called technical services (ts) for assistance with programming this implantable cardioverter defibrillator (icd) system into magnetic resonance imaging (mri) protection mode.Ts confirmed this icd system was mri conditional and assisted with programming.The mri was successfully completed, and ts confirmed the device was functioning as programmed after the mri and that all measurements were within range.It was noted that the medical records showed that the right ventricular (rv) lead was explanted.However, there was confirmation that the lead was repositioned and still in use.It was not determined why the lead was repositioned.An email was sent to medical records to update the information.No adverse patient effects were reported.This rv lead remains in service.
Additional Manufacturer Narrative
This product investigation is still in progress.This report will be updated when product investigation is complete.

• Brand Name: ENDOTAK RELIANCE SG
• 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; PR 00646-2602
• Manufacturer Contact: mark mischke ; 4100 hamline avenue north; saint paul, MN 55112 ; +1(612)875-7234
• MDR Report Key: 50779379
• Report Number: 2124215-2026-49254
• Device Sequence Number: 9939112
• Product Code: NVY
• UDI-Device Identifier: 00802526531248
• UDI-Public: (01)00802526531248(17)200826
• Combination Product (Y/N): Y
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: P910073
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/15/2026

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: 08/26/2020
• Device Model Number: 0292
• Device Catalogue Number: 0292
• Device Lot Number: 440385
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/04/2026
• Initial Report FDA Received Date: 09/15/2026
• Date Device Manufactured: 08/26/2018
• 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: 80 YR
• Patient Sex: Male