MAUDE Adverse Event Report: MPRI SPRINT QUATTRO SECURE S MRI SURESCAN; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)

Model Number 6935M62

Device Problems Pacing Problem (1439); Device Dislodged or Dislocated (2923); High Capture Threshold (3266); Unstable Capture Threshold (3269)

Patient Problem Twiddlers Syndrome (4563)

Event Date 02/23/2023

Event Type  Injury  

Event Description

It was reported that during use of the cardiac resynchronization therapy defibrillator (crt-d) the patient experienced twiddler's syndrome.The twiddler's syndrome caused the right ventricular (rv) lead to pull back to the atrium which then caused pacing problems for the rv lead and the left ventricular (lv) lead since the lead was programmed lv tip to rv coil.It was also reported that the rv lead exhibited high and unstable thresholds.The rv lead was explanted and replaced.The lv lead and crt-d remain in use.No patient complications have been reported as a result of this event.

Manufacturer Narrative

Continuation of concomitant medical products: dtpa2d4 crt-d, implanted: (b)(6) 2022.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.

Manufacturer Narrative

Product event summary: the full lead was returned and analyzed.Returned product analysis was performed and no anomalies were found.The distal low voltage electrode of the lead was covered in body tissue/fibrotic growth.Visual analysis of the lead indicated apparent explant damage.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.

• Brand Name: SPRINT QUATTRO SECURE S MRI SURESCAN
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)
• 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: 16565498
• MDR Text Key: 311502518
• Report Number: 2649622-2023-06787
• Device Sequence Number: 1
• Product Code: LWS
• UDI-Device Identifier: 00643169356566
• UDI-Public: 00643169356566
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P920015
• 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: 04/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 6935M62
• Device Catalogue Number: 6935M62
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/21/2022
• 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: 419488 LEAD, 5076-52 LEAD.
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 73 YR
• Patient Sex: Male