MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION ENTERRA; INTESTINAL STIMULATOR

Model Number 37800

Device Problems Inappropriate/Inadequate Shock/Stimulation (1574); Device Contamination with Chemical or Other Material (2944)

Patient Problem Electric Shock (2554)

Event Type  Injury  

Event Description

The healthcare provider reported via manufacture representative that the patient is reporting "electric shocks" and pain which appear to be caused by stimulation.The device and the device settings have been interrogated on a number of occasions using the nvision programmer whilst following the enterra clinical pathways algorithm.Patient has had previous revision surgery to try and rectify the problem and has been assessed under ga.The healthcare provider found an unknown liquid in the barrel of the enterra device.The leads were cleaned and the device washed out and reconnected, and once again the patient received benefit in the early stages of stimulation.Unfortunately the shocking sensation has now started happening again.The patient has now been listed for further surgery which will involve replacing the old device with a new device and sending this back for analysis.

Manufacturer Narrative

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

• Brand Name: ENTERRA
• Type of Device: INTESTINAL STIMULATOR
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 7000 central ave ne; minneapolis MN 55432
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 7000 central ave ne; minneapolis MN 55432
• Manufacturer Contact: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 12811762
• MDR Text Key: 280759962
• Report Number: 2182207-2021-01987
• Device Sequence Number: 1
• Product Code: LNQ
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 37800
• Device Catalogue Number: 37800
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/02/2021
• 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