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

Model Number 37800

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Paresis (1998); Hernia (2240)

Event Date 06/07/2017

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The patient reported that they had a significant amount of pain since their implant and that after they would eat they would have ga stroparesis.The patient was implanted for a kind of abnormal condition of aspiration pneumonia.Their device worked to help with aspiration pneumonia, but now has symptoms of gastroparesis.Patient stated her "leads are all working and everything's working." the patient had a cat scan done on (b)(6) 2017 to check on the device because they "thought it may be cellulitis or something", and the patient stated that the device didn't even register on the cat scan.It was determined that the patient had developed a small umbilical hernia after the pacemaker was implanted.No further patient complications were reported/ anticipated as a result of this event.

Manufacturer Narrative

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

Event Description

Additional information was received.Health care professional reported the patient's indication for use is gastroparesis.It was reported that the steps taken to resolve the gastroparesis and aspiration pneumonia included placement of the gastric stimulator on (b)(6) 2017.Health care professional reported the patient's past medical history includes: gastroparesis, aspiration pneumonia, splenomegaly, hypoxic brain syndrome factor vii deficiency, pulmonary fibrosis, and htn.No further complications 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.It was reported that the patient had notified their gastroenterologist regarding the reported pain, gastroparesis, and hernia, and the patient had been seen many times on (b)(6) 2017.The surgeon¿s office was also notified.It was noted that the patient¿s weight went up within 6 months; however, their diet actually improved when the pacemaker was inserted, but they could not find the cause of weight gain.Steps taken to resolve the previously reported pain, gastroparesis, and small umbilical hernia included turning off the pacemaker on (b)(6) 2017, which resolved all pain.It was noted that a ct of the abdomen was done on (b)(6) 2017 with no mention of the pacemaker, but hernia; however, the hernia was not addressed by any physician.It was noted no guidance or acknowledgement was given in regards to the umbilical hernia and it was definitely not there before the surgery, but was there now.The patient believed it was related to the pacemaker implant surgery.It was reported the patient¿s pain was never addressed even though it was so bad the patient had to curl up in a ball and had tears in their eyes.Tramadol 50mg was ordered once by the gi doctor for pain.It was noted that during hospitalization in march 2017, the patient had a gastroparesis ¿flare up¿, which was before they had the pacemaker inserted.Regarding the gastroparesis, the patient was told to revert back to the gastroparesis diet.No further complications were reported/anticipated.

• 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: 7152597
• MDR Text Key: 96001816
• Report Number: 3004209178-2017-26762
• 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: consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/28/2018
• Device Model Number: 37800
• Device Catalogue Number: 37800
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/26/2018
• Date Device Manufactured: 05/05/2017
• 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): Other
• Patient Age: 36 YR
• Patient Weight: 127