MAUDE Adverse Event Report: MPRI ATTAIN PERFORMA MRI SURESCAN; DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE

Model Number 429888

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Wound Dehiscence (1154); Syncope (1610); Atrial Fibrillation (1729); Death (1802); Cardiogenic Shock (2262); Pericardial Effusion (3271)

Event Date 01/03/2020

Event Type  Death  

Manufacturer Narrative

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

Event Description

It was reported that the patient contacted the cardiology office complaint of large bloody drainage from the pocket two and half weeks post implant.It was noted the patient was able to manage it conservatively at home.The patient presented to the office 5 days later stating the wound looked worse.It was discovered the wound had dehisced.The patient was treated with antibiotics and the cardiac resynchronization therapy defibrillator (crt-d) system was explanted.The patient is a participant in a clinical study.No further 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.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

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

Event Description

It was further reported that wound tissue cultures were taken and tested for gram positive cocci.Additional antibiotic treatment was given to the patient.

Event Description

It was further reported that on the day of the implant procedure, an effusion was observed and the patient had a drain placed; an ec hocardiogram was performed later that day and the effusion has resolved.Approximately three weeks later, the patient underwent explant of the system due to infection; following removal of the system, the patient had an echocardiogram performed, which showed a small to moderate pericardial effusion.The patient was discharged with a wound vacuum and a wearable cardioverter defibrillator.The patient was admitted two weeks later due to atrial fibrillation (af), which they had no previous history of.A transesophageal echocardiogram (tee) showed a small pericardial effusion and the patient was cardioverted upon admission.The patient then presented approximately eleven weeks later due to a syncopal episode and diagnosed with effusion.A pericardial window was placed the following day.The patient required long-term ventilator and pressor support.The patient was weaned off the ventilator, however, the pressor could not be weaned.The patient declined and was discontinued home to hospice care, where they later passed away due to cardiogenic shock and renal failure.

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.

• Brand Name: ATTAIN PERFORMA MRI SURESCAN
• Type of Device: DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE
• Manufacturer (Section D): MPRI; road 149 km 56.3; villalba PR 00766
• MDR Report Key: 9654411
• MDR Text Key: 177198325
• Report Number: 2649622-2020-02528
• Device Sequence Number: 1
• Product Code: OJX
• UDI-Device Identifier: 00643169601833
• UDI-Public: 00643169601833
• Combination Product (y/n): N
• PMA/PMN Number: P080006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/02/2021
• Device Model Number: 429888
• Device Catalogue Number: 429888
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2020
• Date Manufacturer Received: 05/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DTMA1QQ CRT-D, 5076-52 LEAD, 6935M62 LEAD; (B)(4), 5076-52 LEAD, 6935M62 LEAD
• Patient Outcome(s): Death; Hospitalization; Required Intervention
• Patient Age: 62 YR
• Patient Weight: 70