MAUDE Adverse Event Report: MDT SOFAMOR DANEK PUERTO RICO MFG ENTERRA; INTESTINAL STIMULATOR

Model Number 7425G

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

Patient Problems Nausea (1970); Therapeutic Effects, Unexpected (2099); Vomiting (2144); Distress (2329); Weight Changes (2607)

Event Date 04/16/2003

Event Type  Injury  

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

The consumer reported that the patient had no therapeutic benefit since implant on (b)(6) 2003.The patient started vomiting and at that time weighed (b)(6).The patient had gotten down to where they only weighed (b)(6).Because of all the nausea and vomiting.The patient was very skinny and had to travel to where they got the stimulator placed because they needed a j-tube placed in order to be fed.It was a lot of stress.It was hard to say if the patient had any improvement at all because they were at (b)(6).When they had the j-tube put in and after it was put in, they were able to keep medication in and do things they weren't able to medically do before.The patient did see a little change of doing better, but they were still in the hospital 10 to 15 times a year for at least a week because they had nausea and vomiting and it wouldn't stop.The patient mentioned having diabetes, which had attributed to other health problems they had and gastroparesis.The patient had not had a 50 percent or greater reduction in symptoms.The patient moved on to get implanted with another implant on (b)(6) 2012, the one they currently had now, and their symptoms had improved by 90 percent with the current implant.The indication for use for this patient was gastric stimulation.

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): MDT SOFAMOR DANEK PUERTO RICO MFG; barrio marianna rd 909, km0.4; humacao PR 00792
• Manufacturer (Section G): MDT SOFAMOR DANEK PUERTO RICO MFG; barrio marianna rd 909, km0.4; humacao PR 00792
• Manufacturer Contact: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 5808699
• MDR Text Key: 49982714
• Report Number: 6000032-2016-00089
• 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,Followup
• Report Date: 07/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/28/2004
• Device Model Number: 7425G
• Device Catalogue Number: 7425G
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/29/2016
• Date Device Manufactured: 01/07/2003
• 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
• Patient Age: 34 YR