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

Model Number 3116

Device Problem Low Battery (2584)

Patient Problems Abdominal Pain (1685); Fever (1858); Headache (1880); Pain (1994); Pulmonary Edema (2020); Vomiting (2144); Viral Infection (2248); Malaise (2359); Obstruction/Occlusion (2422)

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.It was reported that the patient was in the hospital and they were fixing the patient¿s spine; it was noted that this was not related to the device or therapy, but that the patient did have flu-like symptoms for a while and a fever, which was why the patient originally went in.It was noted that the patient had been in the hospital for 2 months, they had to make an incision in the patient¿s stomach since the patient was throwing up so badly and had blockage, and they also drained out fluid in the patient¿s lung.It was noted that since the (b)(6) of 2017 or 2016, if the patient turned their neck on the right side, it hurt, so the patient thought their ins might be dead.They indicated that they were experiencing pain on their right side, where the gastric stimulator was located.It was noted the patient blacks out and had epileptic seizures.The patient was redirected to follow up with their healthcare provider (hcp) to have the device checked and get a possible longevity calculation.It was noted that the patient had an appointment on monday.No further complications were reported/anticipated.Additional information was received from a consumer.It was reported that they were experiencing pain on the right side where the gastric stimulator was located.Additional information was received from a healthcare professional (hcp) on (b)(6) 2018.It was reported that the hcp had seen the patient only once and they patient had a history of sickle cell and recurring pancreatic that was not caused by the device, but nothing else was in the patient¿s chart.No further complications were reported/anticipated.

Manufacturer Narrative

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

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 fluid in the patient¿s lungs and flu was related to the device and/or therapy; the patient had to be stuck in their back plenty of times to drain the fluid.It was noted that the circumstances that led to or caused the blockage was that the patient experienced very bad back pain, lower stomach pain, headaches, and falling for no reason.The blockage was noted to have been on the patient¿s stomach and they had to once again have major surgery.No further complications were reported/anticipated.

• 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: 7324265
• MDR Text Key: 101891121
• Report Number: 3004209178-2018-04683
• 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,health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/12/2018

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: 09/28/2012
• 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: 03/08/2018
• Initial Date FDA Received: 03/08/2018
• Supplement Dates Manufacturer Received: 03/08/2018; 03/19/2018
• Supplement Dates FDA Received: 03/08/2018; 04/12/2018
• Date Device Manufactured: 04/05/2011
• 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; Life Threatening; Required Intervention
• Patient Weight: 45