MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO ENTERRA; INTESTINAL STIMULATOR

Model Number 3116

Device Problems Intermittent Continuity (1121); Failure to Deliver Energy (1211); Low Battery (2584); Device Displays Incorrect Message (2591); Battery Problem (2885); Device Operates Differently Than Expected (2913); Insufficient Information (3190)

Patient Problems Nausea (1970); Therapeutic Effects, Unexpected (2099); Vomiting (2144); Therapeutic Response, Decreased (2271); Malaise (2359)

Event Date 03/31/2018

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 consumer regarding a patient with an implantable neurostimulator (ins) for gastric stimulation and gastrointestinal/pelvic floor issues.It was reported that the patient had been really sick since the end of (b)(6) 2018 and went to see the surgeon in the beginning of (b)(6).The doctor said that the battery was depleted, but the main problem aside from nausea and vomiting was constant motion sickness.It was noted that when they checked it, they said the device was going on and off and was giving off error messages.They were informed to reset it and wait 30 days to see if it helped, but the doctor said that it was depleted; they then checked it later and it was not depleted.It was noted that the patient had been in the hospital 3 times ¿ in (b)(6) ¿ was in for 10 days last time, and got discharged last tuesday.The patient went to see their hcp the same day they got out of the hospital and it was showing they still had 6-7 months of battery life, but they knew something was not working right.It was noted that until yesterday for that week, it was working fine, but now the symptoms are all the way back.The surgeon who implanted the device was scheduled to replace it, but the patient had a new surgeon now.The patient was redirected to follow up with their hcp regarding the loss of therapy/sickness.No further complications were reported/anticipated.Additional information was received from a consumer.It was reported that the patient¿s symptoms had not improved and they decided to go to the er.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 received from a consumer (con).It was reported that the patient was getting four different readings in the last two months they were in the hospital and needed a manufacturer representative (rep) to come read the information.

Manufacturer Narrative

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

• Brand Name: ENTERRA
• Type of Device: INTESTINAL STIMULATOR
• Manufacturer (Section D): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; 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: 7638479
• MDR Text Key: 112351954
• Report Number: 3004209178-2018-14352
• Device Sequence Number: 1
• Product Code: LNQ
• 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: Other
• Type of Report: Initial,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: 12/28/2013
• Device Model Number: 3116
• Device Catalogue Number: 3116
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/12/2018
• Initial Date FDA Received: 06/26/2018
• Supplement Dates Manufacturer Received: 07/05/2018; 08/08/2018
• Supplement Dates FDA Received: 07/09/2018; 10/03/2018
• Date Device Manufactured: 07/09/2012
• 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): Hospitalization; Required Intervention
• Patient Age: 40 YR