MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO ENTERRA; INTESTINAL STIMULATOR

Model Number 3116

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

Patient Problems Dehydration (1807); Diarrhea (1811); Pain (1994); Paresis (1998); Therapeutic Effects, Unexpected (2099); No Code Available (3191)

Event Date 02/25/2010

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Information was received from a patient.It was reported that their implantable neurostimulator (ins) never worked for them because their symptoms didn¿t stop.The patient had irritable bowel syndrome with diarrhea (ibsd) and was going to the hospital for dehydration.The patient mentioned that they would have the device removed.The patient was experiencing pain underneath the ins area and had sharp pain when lying on it.The patient stated that nobody could find what was wrong with them.It was noted that the patient had their healthcare provider (hcp) check their battery last year and the ins was low.The patient stated that they tried a different setting and the ins was set low.No further complications were reported or anticipated.Indication for use is gastric stimulation.

Manufacturer Narrative

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

Event Description

Additional information received from a consumer (con).It was reported that the stimulator was working for the patient and, in general, everything was okay.Due to the gastroparesis, the patient had gotten dehydrated multiple times and was taken by an ambulance to the hospital.They thought it was due to their food choices, but it was "hard to determine if this could be device related".It was noted that this had been going on for the past 13 years, probably 15-20 times.

• Brand Name: ENTERRA
• Type of Device: INTESTINAL STIMULATOR
• Manufacturer (Section D): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 7902678
• MDR Text Key: 121491523
• Report Number: 3004209178-2018-21369
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 10/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/28/2011
• Device Model Number: 3116
• Device Catalogue Number: 3116
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/11/2018
• Date Device Manufactured: 11/10/2009
• 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: 55 YR