MAUDE Adverse Event Report: MPRI SPRINT QUATTRO SECURE MRI SURESCAN; DRUG-ELUTING PERMANENT DEFIBRILLATOR ELECTRODES

Model Number 6947M62

Device Problems Failure to Capture (1081); Under-Sensing (1661); Low impedance (2285); Activation, Positioning or Separation Problem (2906); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Cardiac Tamponade (2226); Cardiac Perforation (2513); Complete Heart Block (2627)

Event Date 09/14/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that during a routine cardiac resynchronization therapy defibrillator (crt-d) implant the patient developed chronic heart block and was externally paced until the right ventricular (rv) lead was placed.The remainder of the implant was routine and the patient was discharged.Two weeks later, the rv lead exhibited low pacing impedance, undersensing, and was unable to capture at high outputs; the physician was planning a pericardial centesis for the next day.Three days later, the patient received a sternotomy and it was confirmed the rv lead perforated through the right ventricle and cardiac tamponade occurred.Upon attempt to reposition the lead, the stylet was unable to pass more than a centimeter and the procedure was abandoned.The patient remained hospitalized, and one week later a stylet was still unable to pass.It was decided to explant and replace the lead.Additionally, during the replacement procedure the set screw for the rv port was lost and later found on the floor.The setscrew was replaced with a new one and the grommet was filled with medical adhesive to complete the procedure.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

Product event summary: the full lead was returned and analyzed.Analysis indicated the inner tubing of the lead was extrinsically b reached due to a cut.The overlay tubing and the outer insulation of the lead was extrinsically breached due to a cut.There was blood on the distal conductor /connector pin.Visual analysis of the lead indicated damage at implant.The analyst noted that the lead was returned with a large amount of blood visible along lead length.Visual inspection found two small cuts on the overlay tubing.Using destructive analysis and confirmed that the lead body was cut from the overlay tubing through the multi-lumen tubing.The breach of insulations allows blood ingress into lead body and on conductors.There was also found blood obstructed inside the df-4 pin preventing the stylet insertion.Per the finding and the anomalies described in the event and due to the length of implant, it is likely that the extrinsic insulation breach that was observed during analysis occurred at the time of implant procedure.Insulation breach is likely the cause for the electrical complaints.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 MRI SURESCAN
• Type of Device: DRUG-ELUTING PERMANENT DEFIBRILLATOR ELECTRODES
• Manufacturer (Section D): MPRI; road 149 km 56.3; villalba PR 00766
• MDR Report Key: 10648559
• MDR Text Key: 210390779
• Report Number: 2649622-2020-19423
• Device Sequence Number: 1
• Product Code: NVY
• UDI-Device Identifier: 00643169356627
• UDI-Public: 00643169356627
• 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,health
• Type of Report: Initial,Followup
• Report Date: 10/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/12/2022
• Device Model Number: 6947M62
• Device Catalogue Number: 6947M62
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2020
• Date Manufacturer Received: 10/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DTPB2QQ ICD, 507652 LEAD, 459888 LEAD; DTPB2QQ ICD, 507652 LEAD, 459888 LEAD
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 68 YR
• Patient Weight: 68