MAUDE Adverse Event Report: Medtronic Puerto Rico Villalba CapSure Fix MRI; DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV)

Model Number	5086MRI52
Medical Device Problem Code	Under-Sensing (1661)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/31/2026
Type of Reportable Event	Malfunction

• Brand Name: CapSure Fix MRI
• Common Device Name: DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV)
• Manufacturer (Section D): Medtronic Puerto Rico Villalba; road 149 km 56.3; villalba PR 00766
• Manufacturer (Section G): Medtronic Puerto Rico Villalba; road 149 km 56.3; villalba PR 00766
• Manufacturer Contact: gerard torenvliet ; 8200 coral sea st ne; mounds view, MN 55112--439 ; +1(763)526-9277
• MDR Report Key: 50323918
• Report Number: 2649622-2026-24475
• Device Sequence Number: 21300596
• Product Code: NVN
• UDI-Device Identifier: 00613994657367
• UDI-Public: (01)00613994657367(17)141213
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P090013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/01/2026

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: 12/13/2014
• Device Model Number: 5086MRI52
• Device Catalogue Number: 5086MRI52
• 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: 08/24/2026
• Initial Report FDA Received Date: 08/19/2026
• Supplement Report FDA Received Date: 09/01/2026
• Date Device Manufactured: 01/08/2013
• 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: Required Intervention
• Patient Age: 81 YR
• Patient Sex: Male
• Patient Weight: 68 LB