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Model Number MI2355A
Device Problem Use of Device Problem (1670)
Patient Problems Cardiac Arrest (1762); Hemorrhage/Bleeding (1888); Low Blood Pressure/ Hypotension (1914); Cardiac Tamponade (2226); Cardiac Perforation (2513)
Event Date 06/30/2022
Event Type  Injury  
Event Description
It was reported that, during the implant procedure of a leadless implantable pulse generator (ipg), after the leadless ipg delivery system (ds) tether was cut, the patient experienced a drop in blood pressure, cardiac perforation, resultant cardiac tamponade, confirmed on echocardiogram and cardiac arrest, with resuscitation for 10 minutes. Initially, there was difficulty in inserting the dilator into the leadless implantable pulse generator (ipg) sheath, therefore, the introducer sheath was attempted/not used and replaced with a larger sized sheath. Post first implant attempt, the leadless implantable pulse generator (ipg) dislodged during the pull and hold test. Before the first successful implant, a computerized tomography (ct) confirmed that the leadless ipg and its ds were near the lower cardiac wall, and it was deemed possible that the heart was perforated at this time, possibly relating to positioning/placement. It was immediately after the first successful implantation and cutting the leadless ipg ds tether, that the patient became unstable. After the patient's condition stabilized, post cardiac arrest, a thoracotomy was performed. It was discovered that duringthe thoracotomy that the leadless ipg damaged tine at 9 o'clock, had potentially perforated the heart, where the metal part on the free wall side was visible after thoracotomy. Hemorrhaging was visualized, but it could not be confirmed with other devices, so the procedure was completed. Post treatment, the patient's condition stabilized. The leadless ipg remains in use. Medical intervention was required as a result of this event. No further patient complications have been reported as a result of this event.
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.
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Brand NameMICRA
Manufacturer (Section D)
parkmore business park west
Manufacturer (Section G)
parkmore business park west
Manufacturer Contact
paula bixby
8200 coral sea st ne
mounds view, MN 55112
MDR Report Key15092675
MDR Text Key296468137
Report Number9612164-2022-02799
Device Sequence Number1
Product Code DYB
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 08/31/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/25/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMI2355A
Device Catalogue NumberMI2355A
Device Lot Number00166179
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received08/30/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 07/25/2022 Patient Sequence Number: 1