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

Model Number	439678
Medical Device Problem Codes	Electrical /Electronic Property Problem (1198); Capturing Problem (2891); High Capture Threshold (3266); Unstable Capture Threshold (3269)
Health Effect - Clinical Code	Device Overstimulation of Tissue (1991)
Date of Event	02/26/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Continuation of d10: 680r30 heart ring, implanted: (b)(6) 2018.407645 lead, implanted: (b)(6) 2006.4024-58 lead, implanted: (b)(6) 1998.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 left ventricular (lv) lead exhibited high thresholds that contributed to premature battery depletion of the cardiac resynchronization therapy pacemaker (crt-p).The lv lead was reprogrammed in attempt to conserve the remaining longevity of the device.Approximately one week later, the patient experienced extracardiac stimulation from the lead.The lead was then programmed back to the previous setting.The device and lead remain in use. no further patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Product event summary: the lead was not returned for analysis, however, performance data collected from the device was received and analyzed.Analysis of the device memory indicated pacing capture threshold in the left ventricle was high.Analysis of the device memory indicated pacing capture threshold issue in the left ventricle.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: b5:, h6: device codes: (fdd/annex a), 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.
Event or Problem Description
It was reported, that the left ventricular (lv) lead exhibited high thresholds.That contributed to premature battery depletion of the cardiac resynchronization therapy pacemaker (crt-p).The lv lead was reprogrammed in attempt to conserve the remaining longevity of the device.Approximately one week later, the patient experienced extracardiac stimulation from the lead.The lead was then programmed back to the previous setting.The device and lead remain in use. no further patient complications have been reported, as a result of this event.It was additionally reported, that lv thresholds had previously begun to rise and fluctuate.
Additional Manufacturer Narrative
Product event summary: the lead was not returned for analysis, however, performance data collected from the device was received and analyzed.Analysis of the device memory indicated pacing capture threshold in the left ventricle was high.Analysis of the device memory indicated pacing capture threshold issue in the left ventricle (rising left ventricular threshold).The device memory indicated pacing capture threshold in the left ventricle was unstable.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 ABILITY 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: 18958455
• Report Number: 2649622-2024-07907
• Device Sequence Number: 15775789
• Product Code: OJX
• UDI-Device Identifier: 00613994719096
• UDI-Public: 00613994719096
• Combination Product (Y/N): N
• Initial Reporter State: VT
• Initial Reporter Country: US
• PMA/510(K) Number: P080006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 05/28/2024

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: 07/16/2015
• Device Model Number: 439678
• Device Catalogue Number: 439678
• 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: 02/26/2024
• Supplement Date Received by Manufacturer: 03/27/2024; 05/21/2024; 05/21/2024
• Initial Report FDA Received Date: 03/22/2024
• Supplement Report FDA Received Date: 04/09/2024; 05/21/2024; 05/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/18/2013
• 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: W1TR01 CRT-P, 6725 ADAPTOR
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 81 YR
• Patient Sex: Male