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

Model Number MDT-IPG

Device Problem Invalid Sensing (2293)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/18/2017

Event Type  malfunction  

Manufacturer Narrative

This information is based entirely on journal literature.This event occurred outside the us.All information provided is included in this report.Multiple patients and manufacturers were referenced in the article, but with no manufacturer device/product failure correlation/serial numbers.The gender of the baseline characteristics is female and the baseline age is approximately 69 years old.Possible models include adapta addr and enpulse dr.Since no device id was provided, it is unknown if this event has been previously reported.Request for additional information will be made and upon receipt a supplemental report will be submitted accordingly.The pma number for this report listed is part of a combination of pmas considered the "1-card" and consists of p820003, p850051, p890003, p930022, p970012 and p980035.Referenced article: accuracy of the pacemaker event recorder versus holter-ecg to detect both symptomatic and asymptomatic ventricular arrhythmias.Journal of cardiovascular electrophysiology.2018; 29(1):154-159.Doi: 10.1111/jce.13370.If information is provided in the future, a supplemental report will be issued.

Event Description

A journal article was reviewed which contained information regarding implantable pulse generators (ipgs).Multiple patients and multiple manufacturers were noted in the article; however, a one to one correlation could not be made with unique device serial numbers.The study compared the accuracy of the ipg event recorder versus a holter- electrocardiogram (ecg) to detect symptomatic and asymptomatic ventricular arrhythmias.The article reports that ventricular arrhythmias are underestimated by ipg event recordings.The status of the devices is unknown.Further follow up did not yet yield any additional information.

• 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: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 7477457
• MDR Text Key: 107194011
• Report Number: 2182208-2018-00816
• Device Sequence Number: 1
• Product Code: NVZ
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: 1 CARD
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• 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: 04/03/2018
• Initial Date FDA Received: 05/01/2018
• 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
• Patient Age: 69 YR