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

Model Number 37800

Device Problems Intermittent Continuity (1121); Migration or Expulsion of Device (1395); Therapy Delivered to Incorrect Body Area (1508); Device Operates Differently Than Expected (2913)

Patient Problems Diarrhea (1811); Nausea (1970); Undesired Nerve Stimulation (1980); Pain (1994); Therapeutic Effects, Unexpected (2099); Complaint, Ill-Defined (2331); Ambulation Difficulties (2544); Constipation (3274)

Event Date 09/13/2017

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 that the patient did not know if they were doing something wrong; it felt like the device ¿revs up¿.It was noted that the patient had not had any falls, trauma, or change in activity and the ¿rev¿ was not related to positional movement.The patient was still nauseous and had constipation, diarrhea, no appetite, and a lot of pain in their stomach; the patient had gotten worse.The patient had had the symptoms for ten years, so the device had never helped.It was noted that the patient had an appointment on thursday.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 healthcare professional (hcp).It was reported that actions/interventions taken to resolve the reported issues was temporarily turning the generator off and the cause of the device revving up was not determined as of yet.Additional information was received from a consumer on (b)(6) 2018.It was reported that the device was turned off for 3 days and it was then slowly (weekly) turned back up to see if the patient felt better.It was noted that this was experimental and the patient may have to have a temporary pace maker and then another surgery to put in another spot in the stomach.Nothing else was done for the other symptoms ¿ pain, appetite, nausea, diarrhea, or constipation.It was reported that the patient did not know what led to the device revving up and it revved up no matter what their activity level was; it revved when they were laying down, down their right leg, and it seemed the higher the setting, the worse it was.It was noted that walking was an issue and if felt like the device ¿rolls¿ when the patient walked, bent over, lifted, or squatted; this caused sharp pain where the device was and then it was painful for days after.It was hard for the patient to stand up straight and it made them limp.It was noted that the patient had to wear different clothes now, it had caused the patient their job and the ability to obtain a job, and cost them their life in every way possible.It was noted that it minimally helped their nausea and ability to eat.The patient was going to see if the could ¿handle¿ the device when it finally gets turned up between a 5 or 6.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: 7321704
• MDR Text Key: 101971614
• Report Number: 3004209178-2018-04625
• 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,health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/02/2018

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: 09/14/2018
• Device Model Number: 37800
• Device Catalogue Number: 37800
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/06/2018
• Initial Date FDA Received: 03/07/2018
• Supplement Dates Manufacturer Received: 03/12/2018
• Supplement Dates FDA Received: 04/02/2018
• Date Device Manufactured: 03/15/2017
• 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: 53 YR
• Patient Weight: 58