MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO VILLALBA ATTAIN PERFORMA S MRI SURESCAN; DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE

Model Number	459888
Medical Device Problem Code	High Capture Threshold (3266)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/27/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the left ventricular (lv) lead exhibited high and undefined impedance and high thresholds.The lead was removed.A new lead was attempted but not used as the physician experienced difficulty advancing the guidewire through the lead.A different lead was then implanted.The cardiac resynchronization therapy defibrillator (crt-d) was also explanted and replaced as the reported high thresholds were more quickly draining the battery.The patient is a participant in the post approval clinical surveillance product surveillance registry.It was later reported that lv thresholds had previously increased and dramatic changes in threshold measurements were observed with different vectors.A vector was selected that yielded reasonable capture threshold measurements with a minimum of chest wall sensation.The lead thresholds may have reached non-capture levels.It was further reported during the implant procedure while the lv lead was plugged into the crtd it exhibited elevated pacing threshold, reposition was attempted but did not work.The lv lead was replaced with another lead which initially showed acceptable pacing threshold when connected to the crtd.No 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.
Additional Manufacturer Narrative
Correction: b3 and b5.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 further reported that the initial attempt lv lead high threshold was due to patient anatomy while placing the lead.

• Brand Name: ATTAIN PERFORMA S MRI SURESCAN
• Common Device Name: DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) 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 55112-4391 ; 7635269277
• MDR Report Key: 22929127
• Report Number: 2649622-2025-23825
• Device Sequence Number: 9162429
• Product Code: OJX
• UDI-Device Identifier: 00643169169081
• UDI-Public: (01)00643169169081(17)161104
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: P080006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2015
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/02/2025

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: 11/04/2016
• Device Model Number: 459888
• Device Catalogue Number: 459888
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/08/2025
• Supplement Date Received by Manufacturer: 09/02/2025
• Initial Report FDA Received Date: 08/29/2025
• Supplement Report FDA Received Date: 09/02/2025
• Date Device Manufactured: 12/13/2014
• 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: DTMA1QQ CRTD.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 37 YR
• Patient Sex: Female
• Patient Weight: 63 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White