MAUDE Adverse Event Report: Medtronic Puerto Rico Villalba CapSure Sense Lead MRI SureScan; PERMANENT PACEMAKER ELECTRODE

Model Number	457445
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/07/2026
Type of Reportable Event	Malfunction

• Brand Name: CapSure Sense Lead MRI SureScan
• Common Device Name: PERMANENT PACEMAKER ELECTRODE
• 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: 50541108
• Report Number: 2649622-2026-25866
• Device Sequence Number: 21349123
• Product Code: DTB
• UDI-Device Identifier: 00643169410916
• UDI-Public: (01)00643169410916(17)280116
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• PMA/510(K) Number: P830061
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 457445
• Device Catalogue Number: 457445
• 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: 08/07/2026
• Initial Report FDA Received Date: 09/01/2026
• Date Device Manufactured: 03/06/2026
• 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: 80 YR
• Patient Sex: Female