MAUDE Adverse Event Report: MPRI ATTAIN BIPOLAR OVER THE WIRE LEAD; PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

Model Number 419478

Device Problems Over-Sensing (1438); Under-Sensing (1661); Decreased Sensitivity (2534); Device Sensing Problem (2917)

Patient Problems Chest Pain (1776); Congestive Heart Failure (1783); Dyspnea (1816); Dizziness (2194); No Known Impact Or Consequence To Patient (2692); Heart Failure/Congestive Heart Failure (4446)

Event Date 05/06/2020

Event Type  Injury  

Manufacturer Narrative

Concomitant medical product: dtba1d1, crt-d, implanted: (b)(6) 2016.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the right atrial (ra) lead exhibited intermittent far field r-wave (ffrw) oversensing and the right ventricular (rv) lead exhibited intermittent t-wave oversensing (twos) and the r-wave was below range.Both leads remain in use.No 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.

Manufacturer Narrative

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

Event Description

It was further reported that the patient experienced a "twinging chest pain" and the r wave trend showed various measurements.No further patient complications have been reported as a result of this event.

Event Description

It was further reported that the rv lead was oversensing and several days later undersensing.The lead also exhibited short v-v intervals and the patient experienced shortness of breath and congestive heart 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.

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 further reported that the rv lead triggered a lead integrity alert (lia) for high rate non-sustained episodes and sensing integrity counter(sic).

Event Description

It was further reported that the patient came to the emergency department with dizziness and a fast heart rate.Intermittent twos was observed.The left ventricular lead was noted to be in the right ventricular pace/sense port of the device.The left ventricular lead remains in use.

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 BIPOLAR OVER THE WIRE LEAD
• Type of Device: PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE
• Manufacturer (Section D): MPRI; road 149 km 56.3; villalba PR 00766
• MDR Report Key: 8549778
• MDR Text Key: 143068173
• Report Number: 2649622-2019-07006
• Device Sequence Number: 1
• Product Code: LWP
• Combination Product (y/n): N
• PMA/PMN Number: P010015
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 02/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/14/2009
• Device Model Number: 419478
• Device Catalogue Number: 419478
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 419478 LEAD, 5076-45 LEAD; 419478, LEAD, 5076-45, LEAD.
• Patient Outcome(s): Other
• Patient Age: 55 YR
• Patient Weight: 78