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

Model Number MDT-ICD

Device Problem Reset Problem (3019)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/01/2021

Event Type  Injury  

Event Description

A journal article was reviewed that contained information regarding magnetic resonance imaging (mri) in non-conditional cardiovascular implantable electronic devices.The article reports one patient whose implantable cardioverter defibrillator (icd) exhibited an electrical reset to factory default settings.The device was reprogrammed after the mri.The status/disposition of the device appears to be still in use.No patient complications have been reported as a result of this event.Further follow up did not yet yield any additional information.

Manufacturer Narrative

This information is based entirely on journal literature.Medtronic was made aware of this event through a search of literature publications.Of note, multiple patients and multiple manufacturers 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 male/71 years old.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.A request for additional information will be made and upon receipt a supplemental report will be submitted accordingly.Referenced article: impact of magnetic resonance imaging on functional integrity of non-conditional cardiovascular implantable electronic devices.Pacing and clinical electrophysiology.2021.44:1312¿1319.Doi: 10.1111/pace.14298.If information is provided in the future, a supplemental report will be issued.

• Brand Name: MEDTRONIC ICD
• Type of Device: IMPLANTABLE PACEMAKER PULSE-GENERATOR
• 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: 12925122
• MDR Text Key: 281686031
• Report Number: 2182208-2021-04739
• Device Sequence Number: 1
• Product Code: DXY
• 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,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MDT-ICD
• Device Catalogue Number: MDT-ICD
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/16/2021
• 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 LEADS
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR
• Patient Sex: Male
• Patient Race: White