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

Model Number 3116

Device Problems Overheating of Device (1437); Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problems Abdominal Pain (1685); Nausea (1970); Vomiting (2144); Burning Sensation (2146); Therapeutic Response, Decreased (2271); Electric Shock (2554); Constipation (3274)

Event Date 09/28/2019

Event Type  malfunction  

Manufacturer Narrative

Date of event is an approximation.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a consumer (con) regarding a patient who was implanted with a neurostimulator for gastric stimulation.It was reported that, for the past 4-5 days, the patient¿s foot and leg had an electric shock going on.When the patient went to take a nap on the day of the report, it started burning them where the device was placed and in their stomach.The shock in their foot used to go every four seconds, which was what the pacemaker ran at, but at the time of the report it was a second or two when it shocked their foot.There were no trauma/falls reported that could have been related to the issue.No further complications were reported or anticipated.

Manufacturer Narrative

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

Event Description

Additional information was received from a healthcare professional (hcp).It was reported that the patient had a return of symptoms, including abdominal pain, constipation, nausea, and vomiting.The patient also felt burning and shocking around the implantable neurostimulator (ins) site.It was noted that there was no trauma that prompted this issue.No further complications were reported/anticipated.

• 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: 9156701
• MDR Text Key: 165577675
• Report Number: 3004209178-2019-19016
• 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: 10/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/14/2012
• Device Model Number: 3116
• Device Catalogue Number: 3116
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/03/2019
• Date Device Manufactured: 03/17/2011
• 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 Age: 59 YR