MAUDE Adverse Event Report: MEDTRONIC, INC. ATAKR II; PULSE-GENERATOR, PACEMAKER, IMPLANTABLE

Model Number MDT-UNKNOWN

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

Patient Problems Death (1802); Hematoma (1884); Great Vessel Perforation (2152); Complete Heart Block (2627)

Event Date 01/01/2019

Event Type  Death  

Manufacturer Narrative

Medtronic was made aware of this event through a search of literature publications.It was not possible to ascertain specific device information from the literature publication or to match the event with previously reported events.This information is based entirely on journal literature.This event occurred outside the us.All information provided is included in this report.Patient information is limited due to confidentiality concerns.Of note, multiple patients were noted in the article; however, a one to one correlation could not be made with unique product serial/lot numbers.The baseline gender/age characteristics is female/ 40 years old.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.The date of death is not available at the time of this report; as there is no indication of specific lot number for patient information.A request for additional information will be made and upon receipt a supplemental report will be submitted accordingly.Referenced article: ¿cardiac electrophysiologic procedures ¿ a ten years experience at national institute of cardiovascular diseases, karachi.¿ journal of the pakistan medical association.2019; 69(1):68-71.If information is provided in the future, a supplemental report will be issued.

Event Description

The literature publication reported the following patient complication during the use of a radio frequency ablation catheter: of note, multiple patients were noted in the article; however, a one to one correlation could not be made with unique product serial numbers.The article indicated that there was one (1) patient death which occurred ten hours after the ablation procedure.The article indicated that patient had collapsed ¿immediately on getting up from the bed for ambulation and could not be revived.¿ the article did state that there were no ablation ¿procedure-related complications.¿ the status/disposition of the catheter is unknown.The cause of death has been requested, but not yet received.

• Brand Name: ATAKR II
• Type of Device: PULSE-GENERATOR, PACEMAKER, 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: lisa robertson ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635262723
• MDR Report Key: 8509651
• MDR Text Key: 141777776
• Report Number: 2182208-2019-00702
• Device Sequence Number: 0
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: PK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MDT-UNKNOWN
• Device Catalogue Number: MDT-UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/19/2019
• Initial Date FDA Received: 04/12/2019
• 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 Outcome(s): Death; Required Intervention
• Patient Age: 40 YR