MAUDE Adverse Event Report: MPRI ATTAIN PERFORMA STRAIGHT MRI SURESCAN; DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) P

Model Number	439888
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); High Capture Threshold (3266)
Health Effect - Clinical Codes	Undesired Nerve Stimulation (1980); Device Overstimulation of Tissue (1991)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient experienced diaphragmatic and phrenic nerve stimulation from the left ventricular (lv) lead.Elevated thresholds were also noted on the lead.The lead was capped and replaced.No further patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Continuation of d10: 7122q-65 lead, implanted: (b)(6) 2015, 2088tc-52 lead implanted: (b)(6) 2015 cd3369-40q crt-d implanted: (b)(6) 2023.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, that the patient experienced diaphragmatic.And phrenic nerve stimulation from the left ventricular (lv) lead.Elevated thresholds were also noted, on the lead.The lead was capped and replaced.No further patient complications have been reported, as a result of this event.The lv lead was turned off, prior to replacement.
Additional Manufacturer Narrative
Correction: b5: imf (annex f) health impact codes.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: ATTAIN PERFORMA STRAIGHT MRI SURESCAN
• Common Device Name: DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) P
• Manufacturer (Section D): MPRI; road 149 km 56.3; villalba PR 00766
• Manufacturer (Section G): MPRI; road 149 km 56.3; villalba PR 00766
• Manufacturer Contact: gerard torenvliet ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635269277
• MDR Report Key: 18966390
• Report Number: 2649622-2024-08003
• Device Sequence Number: 17784613
• Product Code: OJX
• UDI-Device Identifier: 00643169002517
• UDI-Public: 00643169002517
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/29/2024

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: 11/12/2016
• Device Model Number: 439888
• Device Catalogue Number: 439888
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/05/2024
• Supplement Date Received by Manufacturer: 05/29/2024
• Initial Report FDA Received Date: 03/23/2024
• Supplement Report FDA Received Date: 05/29/2024
• Date Device Manufactured: 12/12/2014
• 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: CD3365-40Q CRT-D, 2088TC52 LEAD, 7122Q65 LEAD
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Female