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

Model Number 6935M62

Device Problems Deformation Due to Compressive Stress (2889); Activation, Positioning or Separation Problem (2906); Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/26/2021

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that during the implant of the right ventricular (rv) lead, an acute angle was used to place the lead into the patient.The lead was removed from the patient and a stylet could not go to the end of the lead so a kink or damage was suspected.Another lead was used to complete the procedure.No patient complications have been reported as a result of this event.

Manufacturer Narrative

Product event summary: the full lead was returned, analyzed and no anomalies were found.The analysis indicated that a medtronic sample stylet to perform the stylet insertion test.The analyst noted that the test passed with no issues.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.

• Brand Name: SPRINT QUATTRO SECURE S MRI SURESCAN
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)
• Manufacturer (Section D): MEDTRONIC SINGAPORE OPERATIONS; 49 changi south avenue 2; nasaco tech centre; singapore 48605 6; SN 486056
• MDR Report Key: 12446718
• MDR Text Key: 270533664
• Report Number: 3008973940-2021-03244
• Device Sequence Number: 1
• Product Code: LWS
• Combination Product (y/n): N
• PMA/PMN Number: P920015
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/15/2023
• Device Model Number: 6935M62
• Device Catalogue Number: 6935M62
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2021
• Date Manufacturer Received: 09/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 78 YR