MAUDE Adverse Event Report: MEDTRONIC, INC.; ANALYZER, PACEMAKER GENERATOR FUNCTION

Model Number 5311B

Device Problem Output Problem (3005)

Patient Problem Cardiac Arrest (1762)

Event Date 02/02/2014

Event Type  Injury  

Event Description

It was reported that while the analyzer was being used with a temporary pacing lead on a patient, it was noted that the pulse rate of the patient had decreased to lower than 10 bpm on the electrocardiogram monitor, and the patient became unwell.The initial settings are unknown.The same day a permanent implantable pulse generator (ipg) was implanted.Since this model is no longer maintained by the manufacturer, it was recommended to not use this device in the future.The device remains at the hospital.No further patient complications were reported as a result of this event.

Manufacturer Narrative

This event occurred outside the us where the same model is distributed.All information provided is included in this report.Patient information is not generally available due to confidentiality concerns.(b)(4).

• Type of Device: ANALYZER, PACEMAKER GENERATOR FUNCTION
• Manufacturer (Section D): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer (Section G): MEDTRONIC CARDIAC RHYTHM DISEASE MGMT; 8200 coral sea st ne; mounds view MN 55112
• Manufacturer Contact: nashoane fulwood-kelley ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635260583
• MDR Report Key: 3743014
• MDR Text Key: 4414898
• Report Number: 2182208-2014-01006
• Device Sequence Number: 1
• Product Code: DTC
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K884331
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/03/2014

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: Health Professional
• Device Model Number: 5311B
• Device Catalogue Number: 5311B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/03/2014
• Initial Date FDA Received: 04/11/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention