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

Model Number 479878

Device Problems Activation, Positioning or Separation Problem (2906); Device Dislodged or Dislocated (2923); High Capture Threshold (3266)

Patient Problem Fall (1848)

Event Date 10/13/2022

Event Type  Injury  

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 reported that the patient experienced a significant fall event and the left ventricular (lv) lead was suspected to have lead partially dislodged as a result of the fall.Evaluation revealed the lv lead was found to be in the target vessel but had retracted from the initial position distal in the vessel.As a result of the lead retraction, the threshold increased to high outputs and the cardiac resynchronization therapy defibrillator (crt-d) longevity dropped to less than two years.A lv lead revision was scheduled.During the lv lead revision an unsuccessful attempt was made to advance the lv lead over a stylet.A guide catheter was placed and the lv lead was placed distal, secured in the target vessel and lead security was tested.The lv lead threshold testing was performed and found to be acceptable.During the guide catheter removal and slitting the lv lead dislodged.The lv lead was explanted and the crt-d remains in use.No patient complications have been reported as a result of this event.

Manufacturer Narrative

Product event summary: the proximal portion of the lead was returned, analyzed, and no anomalies were found.Visual analysis of the lead indicated apparent explant damage.The analyst noted a proximal segment of the lead 5.5 cm long was returned.Guidewire insertion testing could not be performed as only a proximal segment of the lead was returned.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.

Event Description

It was further reported that the device was explanted and replaced.

• Brand Name: ATTAIN STABILITY QUAD 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: 16147705
• MDR Text Key: 307189117
• Report Number: 2649622-2023-01063
• Device Sequence Number: 1
• Product Code: OJX
• UDI-Device Identifier: 00643169860414
• UDI-Public: 00643169860414
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/26/2024
• Device Model Number: 479878
• Device Catalogue Number: 479878
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/10/2022
• 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: 407652 LEAD, DTMA1QQ CRT-D, 6935M62 LEAD.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Weight: 121 KG