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

Model Number 439888

Device Problems Adverse Event Without Identified Device or Use Problem (2993); High Capture Threshold (3266)

Patient Problems Undesired Nerve Stimulation (1980); Palpitations (2467)

Event Date 06/17/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that the patient experienced fluttering in their chest or palpitations.During a visit to the clinic, it was determined that the patient experienced phrenic nerve stimulation from the left ventricular (lv) lead.The lead was reprogrammed and remains in use.The patient is a participant in a clinical study.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

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

Event Description

The lead was later programmed off due to the phrenic nerve stimulation.

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.

Event Description

It was later reported that the lead had been reprogrammed on multiple occasions prior to being programmed off and that the lead had also exhibited elevated pacing thresholds.Phrenic nerve stimulation was not observed at a subsequent device check.

• Brand Name: ATTAIN PERFORMA STRAIGHT 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: 9733563
• MDR Text Key: 180194151
• Report Number: 2649622-2020-03699
• Device Sequence Number: 1
• Product Code: OJX
• UDI-Device Identifier: 00643169601857
• UDI-Public: 00643169601857
• 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
• Report Date: 05/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/25/2020
• Device Model Number: 439888
• Device Catalogue Number: 439888
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/28/2020
• Initial Date FDA Received: 02/20/2020
• Supplement Dates Manufacturer Received: 02/27/2020; 05/20/2020
• Supplement Dates FDA Received: 03/26/2020; 05/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 5076-52 LEAD, 6935M62 LEAD, DTMA1QQ CRT-D; 5076-52 LEAD, 6935M62 LEAD, DTMA1QQ CRT-D
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR
• Patient Weight: 80