MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. ENTERRA; INTESTINAL STIMULATOR

Model Number 3116

Device Problem Electromagnetic Interference (1194)

Patient Problems High Blood Pressure/ Hypertension (1908); Nausea (1970); Pain (1994); Urinary Frequency (2275); Complaint, Ill-Defined (2331); Abdominal Cramps (2543); Constipation (3274)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

Information was received from a consumer regarding a patient who was implanted with a neurostimulator for gastric stimulation and gastrointestinal/pelvic floor.It was reported that in (b)(6) 2016 the patient went through security and they wanded her, and the patient started feeling funny when they wanded her.The patient also had 2 ct scans in (b)(6) 2016.It was noted that she was coming due to have the device adjusted because she was getting more nauseous, started earlier in (b)(6) 2016.The patient also thought her back problems were causing problems with her bladder.She was getting up 6 times per night.She had a sonogram and they said her bladder is narrowing to the size of a straw.There were also abdominal problems and it started with constipation.Sometimes food would go right through her and she would get severe abdominal cramps.There was a sharp constant pain on the left side, which was the side the device was on.This started about a month or month and a half ago.The patient's blood pressure was up starting a month ago.It was like 104, 102, 98 and 99 two nights ago.It was noted that the patient was doing physical therapy three times a week.Further follow-up is being conducted to determine what steps were taken to resolve the issues and if the issues had been resolved.If additional information is received, the event will be updated.

• Brand Name: ENTERRA
• Type of Device: INTESTINAL STIMULATOR
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• 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: 5501160
• MDR Text Key: 40633314
• Report Number: 3004209178-2016-04589
• 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: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/28/2016
• Device Model Number: 3116
• Device Catalogue Number: 3116
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/18/2016
• Date Device Manufactured: 12/13/2014
• 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