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

Model Number 3116

Device Problems Energy Output Problem (1431); Impedance Problem (2950); Insufficient Information (3190)

Patient Problems Dyspnea (1816); Pyrosis/Heartburn (1883); Nausea (1970); Vomiting (2144); Complaint, Ill-Defined (2331)

Event Date 06/12/2018

Event Type  Injury  

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 the patient was experiencing more heartburn, acid reflux, vomiting, and got heartburn at night when they went to bed.These were noted to be sudden changes.They went to the healthcare professional¿s (hcp) office on the morning of the report to check the device and were told that the battery needed to be replaced and 1-2 leads were not within impedance tolerance.The hcp turned the therapy off, which took the patient¿s breath away.The patient needed to find a physician to perform the surgery.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 received from a consumer (con).It was reported that the patient found a surgeon who would handle the surgery.For 2-3 months prior to the report, the patient noticed that they were nauseated in the mornings again.They also had heartburn and their acid reflux returned, noting that they took 40 mg of prilosec daily.The patient had an appointment scheduled with the surgeon for (b)(6), when they'll fix the battery and leads.The patient noted that the device was not on and there was no date set for a surgery.

• 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: 7877324
• MDR Text Key: 120404942
• Report Number: 3004209178-2018-20690
• 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: 10/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/28/2012
• Device Model Number: 3116
• Device Catalogue Number: 3116
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/24/2018
• Date Device Manufactured: 06/01/2011
• 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 Outcome(s): Required Intervention
• Patient Age: 60 YR
• Patient Weight: 70