MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO VILLALBA ATTAIN ABILITY MRI SURESCAN; DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) P

Model Number	419688
Medical Device Problem Codes	Over-Sensing (1438); High Capture Threshold (3266)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/14/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Continuation of d10: dtpb2d1 crt-d implanted: (b)(6) 2026.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.
Event or Problem Description
It was reported by the patient representative that one of the "right ventricular (rv) lead pins was not working right." "the rv lead could not be inserted." the "cyclone has risen and "won't stay in the cardiac resynchronization therapy defibrillator (crt-d)"."the rv pin wasn't long enough to stay in the crt-d"."they had disconnected the rv lead from the crt-d and so the patient has two leads currently active"."the rv lead did not plug in".The rv lead remains in the patient.Follow up with the clinic indicated that following a generator change out, the rv lead exhibited failure to capture and high pacing impedance.The device pocket was reopened and inspection of the leads showed that the rv lead was connected to the header screw, and the connector pin was shorter than expected.It was noted that the mechanism for the short pin was unclear.The pace/sense portion of the rv lead was capped, and the defibrillation portion remains in use.A new rv lead pace/sense lead was attempted, but there was occlusion of the left subclavian venous system around the older leads.The physician elected to plug the left ventricular (lv) lead into the rv pace/sense port and plug the lv port to allow for normal defibrillation function, but lv only pacing.It was further reported that there was t-wave oversensing (twos) and high rv thresholds.Reprogramming was performed.The lv lead remains in use.No patient complications have been reported as a result of this event.

• Brand Name: ATTAIN ABILITY MRI SURESCAN
• Common Device Name: DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) P
• 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 55112-4391 ; 7635269277
• MDR Report Key: 25552513
• Report Number: 2649622-2026-18227
• Device Sequence Number: 10741176
• Product Code: OJX
• UDI-Device Identifier: 00613994469731
• UDI-Public: (01)00613994469731(17)110601
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P080006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/18/2026

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: 06/01/2011
• Device Model Number: 419688
• Device Catalogue Number: 419688
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/19/2026
• Initial Report FDA Received Date: 06/18/2026
• Date Device Manufactured: 01/12/2011
• 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: 694758 LEAD, 407645 LEAD
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 79 YR
• Patient Sex: Female