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

Model Number 3116

Device Problem Low Battery (2584)

Patient Problems Paresis (1998); Therapeutic Response, Decreased (2271); Complaint, Ill-Defined (2331)

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 last time the patient saw their physician, the healthcare provider (hcp) noted that they did not plan to replace the battery when it died at that point because the patient was not having a lot of episodes or hospitalizations.The patient felt that it was because they had the implant and the implant was doing what it was supposed to.It was noted that with the implant, the patient could not have an mri and their back surgeons were concerned that the implant had been in a lot longer than the therapy had, and if the battery went dead and there was no point in replacing it, then they want it removed.It was clarified that the patient only had one implant and the hcp that implanted the device was no longer at the hospital.The patient was told that the battery lasted only 7-10 years, and it had been 13 years this coming year, so the patient had to assume that it was not functioning anymore.About 3 years ago, the patient had symptoms all the time, their symptoms returned, and they had a few hospitalizations as a result.The patient found some doctors and would contact them to further discuss.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.It was reported that the patient had idiopathic gastroparesis and continued to have periodic episodes.It was noted that the patient had no idea if the battery was depleted, but it had been 13 years.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: 7280729
• MDR Text Key: 100408003
• Report Number: 3004209178-2018-03563
• 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
• Report Date: 04/24/2018

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: 07/28/2006
• 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: 02/16/2018
• Initial Date FDA Received: 02/19/2018
• Supplement Dates Manufacturer Received: 04/05/2018
• Supplement Dates FDA Received: 04/24/2018
• Date Device Manufactured: 02/02/2005
• 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
• Patient Weight: 76