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

Model Number 37800

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

Patient Problems Abdominal Pain (1685); Nausea (1970); Paresis (1998); Urinary Tract Infection (2120); Vomiting (2144); Cramp(s) (2193); Obstruction/Occlusion (2422)

Event Date 08/06/2018

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 healthcare professional (hcp) regarding a patient who was implanted with a neurostimulator for gastric stimulation.It was reported that the patient was admitted to the hospital with symptoms related to gastroparesis.They were having nausea, vomiting, cramping, and severe abdominal pain.These were noted to be a sudden change and began around noon the day prior to the report.They also reported they were admitted due to small bowel obstruction and a urinary tract infection (uti).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 healthcare professional (hcp) via a manufacturer representative (rep).It was reported that the cause of the sudden return of gastroparesis symptoms was caused by the uti and small bowel obstruction.Medication was given to the patient for the uti and small bowel obstruction, but it was not noted if it was resolved.

Manufacturer Narrative

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

Manufacturer Narrative

(b)(4) as it was reported that the obstruction was due to adhesions, not the device, therapy, or procedure.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information received from a manufacturer representative (rep).It was reported that the uti and small bowel obstruction was not related to the device or implant procedure.The patient had a history of utis and the cause of the small bowel obstruction was due to adhesions.

• Brand Name: ENTERRA
• Type of Device: 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: 7767009
• MDR Text Key: 116541741
• Report Number: 3004209178-2018-17681
• Device Sequence Number: 1
• Product Code: LNQ
• UDI-Device Identifier: 00643169614246
• UDI-Public: 00643169614246
• Combination Product (y/n): N
• PMA/PMN Number: H990014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/03/2018

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
• Device Operator: Health Professional
• Device Expiration Date: 02/14/2018
• Device Model Number: 37800
• Device Catalogue Number: 37800
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/07/2018
• Initial Date FDA Received: 08/09/2018
• Supplement Dates Manufacturer Received: 08/22/2018; 09/07/2018; 08/08/2018
• Supplement Dates FDA Received: 08/28/2018; 09/19/2018; 10/02/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 64 YR