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

Model Number 6947M62

Device Problems Break (1069); Failure to Capture (1081); Device Contamination with Body Fluid (2317); Device Dislodged or Dislocated (2923)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/11/2020

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 377176 lead, implanted: (b)(6) 2018.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that within a few hours of implant, the right ventricular (rv) lead exhibited a loss of capture.It was suspected t hat the lead had dislodged due to a loss of slack, as it had not been possible to sufficiently advance the superior vena cava (svc) coil past a certain spot due to the patient's anatomy.The lead was explanted and replaced with a single coil lead.After explant, it was observed that blood was present within the silicone sheathing, and it was suspected that a breach had occurred.No 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 outer insulation of the lead was extrinsically breached due to a cut.There was blood on the distal conductor of the lead and it was not obstructed.The distal low voltage electrode of the lead was covered in body tissue/fibrotic growth.The overlay tubing of the lead was extrinsically breached due to a cut.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.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: 10212784
• MDR Text Key: 196967853
• Report Number: 2649622-2020-12428
• 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: 08/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/13/2021
• Device Model Number: 6947M62
• Device Catalogue Number: 6947M62
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2020
• Date Manufacturer Received: 08/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DDMB1D4 ICD; DDMB1D4 ICD
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 77 YR