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

Model Number 419688

Device Problems Capturing Problem (2891); Unstable Capture Threshold (3269)

Patient Problems Syncope/Fainting (4411); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/22/2016

Event Type  Injury  

Event Description

It was reported that the patient complaint of syncope two times in the past few months while laying down.The physician suspected patient was having vertigo and the patient attended physical therapy with questionable results.The right ventricular (rv) lead is programmed rv subthreshold since shortly after implant due to high thresholds, and sometimes no capture at maximum output.The left ventricular feature that monitors and captures the pacing amplitude threshold and adjusts lv outputs, trend data show a baseline of variable thresholds but more variation in the past few months.The lv lead was tested but there was a 1 volt difference in threshold when patient was laying on the left side versus the ride side.The left ventricular output monitor and capture feature was programmed to monitor and thresholds re-programmed.A review of the device data did not reveal a lead integrity issue, including the positional threshold changes.The lv lead remains in use.Subsequently, the rv lead was capped and replaced.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

The lead was not returned for analysis, however, performance data collected from the device was received and analyzed.The device memory indicated pacing capture threshold in the left ventricle was unstable.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

It was confirmed that the patient experienced syncope due to the rv lead exhibiting no capture at maximum outputs and the lv lead thresholds increasing.

• Brand Name: ATTAIN ABILITY MRI SURESCAN
• Type of Device: 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: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 15955070
• MDR Text Key: 305237167
• Report Number: 2649622-2022-25323
• Device Sequence Number: 1
• Product Code: OJX
• UDI-Device Identifier: 00643169601772
• UDI-Public: 00643169601772
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P080006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/01/2018
• Device Model Number: 419688
• Device Catalogue Number: 419688
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/09/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/05/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: 5076-45 LEAD, 5076-52 LEAD, C4TR01 CRT-P
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 60 YR
• Patient Sex: Male