MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION UNKNOWN ENTERRA STIMULATOR; INTESTINAL STIMULATOR

Model Number NEU_ENTERRA_INS

Device Problems Device Operates Differently Than Expected (2913); Device Contamination with Chemical or Other Material (2944); Impedance Problem (2950)

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

Event Date 11/25/2016

Event Type  Injury  

Event Description

A healthcare professional (hcp) via a manufacturer representative reported removing a malfunctioning device.There was moisture in the lead chamber and out of range impedances.Once dried out, read properly.The device was from 2012 and the hcp put in a new generator.It was unknown if any troubleshooting was performed.The issue was noted as resolved at the time of the report.

• Brand Name: UNKNOWN ENTERRA STIMULATOR
• Type of Device: INTESTINAL STIMULATOR
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• Manufacturer Contact: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 6183859
• MDR Text Key: 62671570
• Report Number: 3007566237-2016-04452
• Device Sequence Number: 1
• Product Code: LNQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: H990014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NEU_ENTERRA_INS
• Device Catalogue Number: NEU_ENTERRA_INS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/25/2016
• 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
• Patient Outcome(s): Required Intervention