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

Model Number NEU_ENTERRA_INS

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

Patient Problems High Blood Pressure/ Hypertension (1908); Nausea (1970); Vomiting (2144); Constipation (3274)

Event Date 10/08/2015

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id 4351, product type: lead.(b)(4).

Event Description

A healthcare provider (hcp) for a clinical study reported the patient remained hospitalized after implant for nausea, vomiting, and uncontrolled hypertension due to her inability to take oral medication for hypertension.The patient was admitted to the floor post-operation and given npo (nil per os) status post-surgery secondary to no return of bowel function, the patient spitting up, and she was unable to take her home dose of labetalol and her blood pressure became uncontrollably elevated.The patient was transferred to the surgical intensive care unit and placed on a nicardipine drip.She was also started on erythromycin and thereafter resumed bowel function.Her blood pressure stabilized and she was able to tolerate po (per os - oral administration of medication).Her home po labetalol was restarted and she was then transferred back to the floor.Her blood pressure was stable on the floor and she was deemed stable for discharge with restart of her insulin pump, outpatient endocrine follow up, and follow up with her physician in a week as an outpatient.The problem was not with the patient's device.The nausea, vomiting, and hypertension resolved.If additional information is received, a follow-up report will be sent.

• Brand Name: UNKNOWN ENTERRA NEUROSTIMULATOR
• Type of Device: INTESTINAL STIMULATOR
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 7000 central avenue ne rcw215; minneapolis MN 55432
• Manufacturer Contact: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 5202004
• MDR Text Key: 30451448
• Report Number: 3007566237-2015-03206
• 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: health professional,study
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/14/2015

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: NEU_ENTERRA_INS
• Device Catalogue Number: NEU_ENTERRA_INS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/14/2015
• Initial Date FDA Received: 11/04/2015
• 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): Hospitalization; Required Intervention