MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INGEVITY? MRI; Implantable Lead

Model Number	7740
Medical Device Problem Codes	Failure to Capture (1081); High impedance (1291); Low impedance (2285)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/29/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the implantable cardioverter defibrillator (icd) and this right atrial (ra) lead exhibited a high out of range pacing impedance.The pacing impedance ranged from 500-600 ohms, then started to dip into 200 ohms, then went to greater than 3000 ohms and has stayed at that measurement.Also, technical services (ts) reviewed presenting electrograms (egm) and suspected there was a loss of capture on this ra lead and the right ventricular (rv) lead.Ts recommended evaluating lead threshold with surface in clinic.Ts confirmed the icd had an appropriate safety margin based on the last in office measurement.This ra lead remains in service.No adverse patient effects were reported.
Additional Manufacturer Narrative
If pertinent information is provided in the future, a supplemental report will be submitted.This product investigation is still in progress.This report will be updated when product investigation is complete.

• Brand Name: INGEVITY? MRI
• 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: 50602212
• Report Number: 2124215-2026-45921
• Device Sequence Number: 13401754
• Product Code: NVN
• UDI-Device Identifier: 00802526523427
• UDI-Public: (01)00802526523427(17)180614
• Combination Product (Y/N): Y
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P150012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/09/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 06/14/2018
• Device Model Number: 7740
• Device Catalogue Number: 7740
• Device Lot Number: 638057
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 08/31/2026
• Initial Report FDA Received Date: 09/04/2026
• Supplement Report FDA Received Date: 09/09/2026
• Date Device Manufactured: 06/14/2016
• 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
• Patient Age: 46 YR
• Patient Sex: Male