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

Model Number 37800

Device Problems Premature Discharge of Battery (1057); Energy Output Problem (1431); Unexpected Therapeutic Results (1631); Insufficient Information (3190)

Patient Problems Vomiting (2144); Complaint, Ill-Defined (2331); Malaise (2359)

Event Date 01/01/2018

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).It was reported the patient¿s battery only seemed to last a year and a half.The caller reported the implant had malfunctioned, stopped working, the battery had died.The caller noted the implant was acting up several months ago.The caller stated the implant started working again for about a month, but 3 weeks prior to the call the implant ¿failed¿.The caller stated because of this, the patient was unable to keep anything good down.There were no further complications that have been reported 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 from a consumer.It was reported that the patient¿s current implantable neurostimulator (ins) was placed in (b)(6) 2017 and this was by far the worst ins and was not working as well as the previous one, it was not working shortly after it was placed since implant, and the patient had nothing but issues of flare ups.It was noted that the healthcare provider (hcp) checks the impedances at each appointment, and the patient noticed the settings were high, but don¿t seem to shock the right way.The patient thought that the ins was dead back in (b)(6) and went to the hcp; however, it showed that it was ok, but the patient did not know if the battery was indeed showing it was working fine.It was noted all of the patient¿s symptoms had come back ¿full force¿ and had come in spurts since implant, and the patient could not eat a week after implant.The patient went to see their doctor and it was adjusted, and the patient did good until (b)(6) 2018, but the patient had a ¿flare¿ in (b)(6) 2018, and the doctor adjusted the device and the patient did better.The patient had another ¿flare¿ in (b)(6) 2018, had been sick since then, and could not keep anything down.It was noted that between all of these episodes, the patient was throwing up at least once a week since implant.It was noted that it was almost like the ins was not delivering stimulation like it should.Impedance checks were noted to have come back fine, and the doctor turned stimulation up really high and for now it was working, but the patient was still having issues around diner time when they tried to eat and threw up since (b)(6) 2018.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: 7855459
• MDR Text Key: 120471646
• Report Number: 3004209178-2018-20105
• Device Sequence Number: 1
• Product Code: LNQ
• UDI-Device Identifier: 00643169614246
• UDI-Public: 00643169614246
• 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: 10/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/14/2019
• Device Model Number: 37800
• Device Catalogue Number: 37800
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/11/2018
• Date Device Manufactured: 07/20/2017
• 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 Age: 26 YR