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

Model Number	3116
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Abdominal Pain (1685); Nausea (1970)
Date of Event	01/26/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Information was received from a healthcare provider regarding a patient who was implanted with an implantable neurostimulator (ins) for gastric stimulation and gastrointestinal/pelvic floor therapy.It was reported that the patient is having constant nausea, vomiting, abdominal pain and no medications are helping.Caller reports this has been occurring the past 3 weeks.The patient called to reported again that they are not sure if battery is still working.The patient is requesting to get manufacturer representative (rep) to check ins due to this.They are not sure if hcp that called yesterday has heard back regarding requesting rep as hcp is not in office today.Reviewed process to contact rep and redirected patient to hcp to contact/inquire if able to contact rep.Provided the patient with nas pelvic health number for hcp if needed.

• Brand Name: ENTERRA
• Common Device Name: INTESTINAL STIMULATOR
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• MDR Report Key: 11350329
• Report Number: 3004209178-2021-02909
• Device Sequence Number: 4045167
• Product Code: LNQ
• UDI-Device Identifier: 00643169174993
• UDI-Public: 00643169174993
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: H990014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/14/2016
• Device Model Number: 3116
• Device Catalogue Number: 3116
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/16/2021
• Initial Report FDA Received Date: 02/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 40 YR