MAUDE Adverse Event Report: RICE CREEK MFG

Model Number EPG-MEDT

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/05/2015

Event Type  Injury  

Manufacturer Narrative

The information submitted reflects all relevant data received.If additional relevant information is received, a supplemental report will be submitted.Without a lot number or device serial number, the manufacturing date cannot be determined.(b)(4).

Event Description

It was reported that an incident occurred with the external pulse generator (epg) patient cable.Follow up indicated that the incident involved difficulty with the epg.A new cable was successfully used.The cable is expected to be returned.The epg remains in use.No patient complications have been reported as a result of this event.

• Manufacturer (Section D): RICE CREEK MFG; 7000 central ave ne; fridley MN 55432
• Manufacturer (Section G): MEDTRONIC CARDIAC RHYTHM HEART FAILURE; 8200 coral sea st ne; mounds view MN 55112
• Manufacturer Contact: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 5132777
• MDR Text Key: 27774782
• Report Number: 6000030-2015-00147
• Device Sequence Number: 1
• Product Code: DTE
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Reporter Occupation: Other
• Report Date: 08/05/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2015
• 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?: No
• Date Manufacturer Received: 08/05/2015
• 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): Required Intervention