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

Model Number	383069
Medical Device Problem Codes	Failure to Capture (1081); Device Dislodged or Dislocated (2923); High Capture Threshold (3266)
Health Effect - Clinical Code	Twiddlers Syndrome (4563)
Date of Event	09/10/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that seven weeks post implant the right atrial (ra) lead and right ventricular (rv) left bundle branch (lbb) lead dislodged.The rv lbb lead exhibited high thresholds and intermittent capture.The ra lead exhibited no capture and no sensing.The physician was suspicious of twiddler's syndrome due to the lack of slack and possible twists in the leads seen on x-ray. upon opening the pocket, knots were seen in the lead coils, indicating the dislodgement was due to twiddlers' syndrome. the rv lbb lead was reprogrammed.The ra lead and rv lbb leads were explanted and replaced.No further patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: SelectSecure MRI SureScan
• 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: 50946253
• Report Number: 2649622-2026-28895
• Device Sequence Number: 21445611
• Product Code: NVN
• UDI-Device Identifier: 00763000740269
• UDI-Public: (01)00763000740269(17)280421(20)01
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: P030036
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/30/2026

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 Model Number: 383069
• Device Catalogue Number: 383069
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Fifteen-Day
• Initial Date Received by Manufacturer: 09/10/2026
• Initial Report FDA Received Date: 09/30/2026
• Date Device Manufactured: 04/29/2026
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 5076-45 LEAD, W1DR01 IPG
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 89 YR
• Patient Sex: Female