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

Model Number 37800

Device Problem Electromagnetic Compatibility Problem (2927)

Patient Problems Vomiting (2144); Therapeutic Response, Decreased (2271)

Event Date 08/13/2018

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 gastrointestinal/pelvic floor.It was reported they were having issues with the battery of their ins.It was noted the caller was transferred to patient services.Additional information from the consumer on august 31st reported the patient had a leg amputation surgery and was intensive care and they were concerned because she had been throwing up for about 4 days.The caller noted they went to the emergency room (er) because the patient¿s foot was hurting her and then they found she had an infection in her leg and was septic all the sudden so they had to amputate her leg on (b)(6).The caller stated that the throwing up, had a return of symptoms sometime in the middle of (b)(6).The caller noted since the amputation on (b)(6), the patient stump is now infected and said they might have to amputate the patient¿s other leg, but they want to have the device checked before the surgery.There were no further complications that hav e been reported as a result of this event.

• 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: 7865097
• MDR Text Key: 123069950
• Report Number: 3004209178-2018-20356
• 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: consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/11/2018

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: 05/28/2016
• Device Model Number: 37800
• Device Catalogue Number: 37800
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/31/2018
• Initial Date FDA Received: 09/11/2018
• Date Device Manufactured: 12/08/2014
• 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: 42 YR