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

Model Number 37800

Device Problems Failure to Deliver Energy (1211); Device Operates Differently Than Expected (2913)

Patient Problems Abdominal Pain (1685); Hematoma (1884); Therapeutic Effects, Unexpected (2099); Thrombosis (2100); Therapeutic Response, Decreased (2271); Complaint, Ill-Defined (2331); Malaise (2359)

Event Date 03/02/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Information was received from a consumer regarding a patient with an implantable neurostimulator (ins) for gastric stimulation and gastrointestinal/pelvic floor issues.It was reported that the patient thought their device was not working, they were really sick and had a return of symptoms, had stomach pain for a month and was not eating, they did not feel stimulation and the doctor turned it up a while ago; they usually felt the pulse when in bed and they couldn¿t feel it.It was noted that the patient had a bowel movement that was pure blood and blood clots.The patient went to the hospital yesterday and they put a stethoscope to the battery and they could not hear it working.The patient was redirected to follow up with their healthcare provider (hcp) and to have the device checked with a clinician programmer.No further complications were reported/anticipated.

Manufacturer Narrative

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

Event Description

Additional information was received from a consumer (con) via a manufacturer representative (rep).It was reported that the patient was having issues with the therapy.They had an appointment with their doctor in two weeks after the report.

• 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
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; 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: 7396497
• MDR Text Key: 104472107
• Report Number: 3004209178-2018-06459
• Device Sequence Number: 1
• Product Code: LNQ
• UDI-Device Identifier: 00643169360686
• UDI-Public: 00643169360686
• 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: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/28/2016
• Device Model Number: 37800
• Device Catalogue Number: 37800
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/10/2018
• Date Device Manufactured: 04/29/2015
• 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: 48 YR