MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION ENTERRA; INTESTINAL STIMULATOR

Model Number 37800

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Nausea (1970); Pain (1994); Complaint, Ill-Defined (2331); Abdominal Distention (2601)

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 4351-35.Implanted: (b)(6) 2018, product type: lead; product id: 4351-35, implanted: (b)(6) 2018, product type: lead.If information is provided in the future, a supplemental report will be issued.

Event Description

The patient¿s healthcare provider reported via manufacture representative that the patient presented at the clinic on (b)(6) 2018 for a routine checkup.The nurse made step changes from 5 ma to 7.5 ma as per pathway as the patient still experienced nausea although there was improvement.The patient reported a distended tummy and pain after one-hour post programming change.It was noted that at the patient¿s previous appointment only a nominal change had occurred.No environmental/external/patient factors were noted that may have led or contributed to the issue.The patient was scheduled to see their healthcare provider on (b)(6) 2018 to change the settings back to 5 ma.No further complications were reported.Additional information reported that had volvulus, ischaemic bowel and had a right side hemicolectomy.It was unknown if the event was resolved.No further complications were reported.Additional information reported that the patient was discharged (b)(6) 2018 and had a follow up in the clinic (b)(6) 2019.The patient¿s healthcare provider did not feel that the volvulous was connected to the device programming.

Manufacturer Narrative

Continuation of concomitant medical products: product id: 4351-35, serial# unknown, implanted: (b)(6) 2018, product type: lead; product id: 4351-35, serial# unknown, implanted: (b)(6) 2018, product type: lead.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information reported that the patient is well, the issue resolved and there appeared to be no connection to enterra.No further complications were reported.

• Brand Name: ENTERRA
• 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: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 8157251
• MDR Text Key: 130172183
• Report Number: 3007566237-2018-03581
• Device Sequence Number: 1
• Product Code: LNQ
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: H990014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/31/2019

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?: No
• Device Operator: Health Professional
• Device Model Number: 37800
• Device Catalogue Number: 37800
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/16/2018
• Initial Date FDA Received: 12/12/2018
• Supplement Dates Manufacturer Received: 01/23/2019
• Supplement Dates FDA Received: 01/31/2019
• 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
• Patient Age: 46 YR