MAUDE Adverse Event Report: MEDTRONIC, INC. MEDTRONIC IPG; PULSE GENERATOR, PERMANENT, IMPLANTABLE

Model Number MDT-IPG

Device Problem Pacing Problem (1439)

Patient Problems Arrhythmia (1721); Tachycardia (2095)

Event Date 01/01/2015

Event Type  Injury  

Event Description

Literature was reviewed regarding inappropriate tachycardia at rest.The authors described a patient who reported exercise intolerance and palpitations at rest approximately one year post pacemaker implant.After device interrogation, it was noted that the atrial preference pacing (app) feature was turned on and the high atrial rate episodes because of app caused palpitations at rest and exercise intolerance.The device was reprogrammed, and the patient's symptoms resolved.The device remains in use.No additional adverse patient effects or product performance issues were reported.

Manufacturer Narrative

This information is based entirely on journal literature.Medtronic was made aware of this event through a search of literature publications.This event occurred outside the us.Patient information is limited due to confidentiality concerns.The event only occurred with one patient but specific details on the patient were not provided.The model listed in the report is a representative of the model family, as there is no specific model listed.Without a lot number or device serial number, the manufacturing date cannot be determined.Since no device id was provided, it is unknown if this event has been previously reported.Referenced article: inappropriate tachycardia at rest as a consequence of atrial preference pacing algorithm.Revista portuguesa de cardiologia.2020; 39(12): 729.E1-729.E4.Doi: 10.1016/j.Repc.2020.05.014.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: MEDTRONIC IPG
• Type of Device: PULSE GENERATOR, PERMANENT, IMPLANTABLE
• Manufacturer (Section D): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer (Section G): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer Contact: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 19143797
• MDR Text Key: 340601072
• Report Number: 2182208-2024-01714
• Device Sequence Number: 1
• Product Code: NVZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/19/2024

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?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MDT-IPG
• Device Catalogue Number: MDT-IPG
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/19/2024
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: UNKNOWN COMPETITOR LEAD.
• Patient Outcome(s): Required Intervention
• Patient Age: 34 YR
• Patient Sex: Female