MAUDE Adverse Event Report: RICE CREEK MFG MEDTRONIC EPG; PULSE-GENERATOR, PACEMAKER, EXTERNAL

Model Number EPG-MEDT

Device Problems Connection Problem (2900); Material Integrity Problem (2978); Output Problem (3005); Power Problem (3010); Unexpected Shutdown (4019)

Patient Problems Arrhythmia (1721); Tachycardia (2095)

Event Date 01/01/2019

Event Type  Death  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that external pulse generators (epgs) were directly related to patients experiencing tachycardia and fibrillation.It was further reported that these events were related to the device (epg) settings, epg connection issues, external epg cabling issues and loss of power to the epg.The current status of the epgs is unknown.It was indicated that the events led to patient death.There is no additional information available.

• Brand Name: MEDTRONIC EPG
• Type of Device: PULSE-GENERATOR, PACEMAKER, EXTERNAL
• Manufacturer (Section D): RICE CREEK MFG; 7000 central ave ne; fridley MN 55432
• Manufacturer (Section G): RICE CREEK MFG; 7000 central ave ne; fridley MN 55432
• Manufacturer Contact: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 8746606
• MDR Text Key: 149611578
• Report Number: 6000030-2019-00062
• Device Sequence Number: 1
• Product Code: DTE
• Combination Product (y/n): N
• Reporter Country Code: SP
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EPG-MEDT
• Device Catalogue Number: EPG-MEDT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/31/2019
• 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): Death