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

Model Number 37800

Device Problems Intermittent Continuity (1121); Vibration (1674)

Patient Problems Emotional Changes (1831); Nausea (1970); Pain (1994); Seroma (2069); Vomiting (2144); Weight Changes (2607); Insufficient Information (4580)

Event Date 07/18/2019

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) for the treatment of gastric stimulation.It was reported that the patient¿s device was ¿pulsing¿ and they could feel it if they touched it.They stated they had a recording of the ins ¿twitching, and it kind of hurt when it does it¿.They stated once it was so bad they started crying.They also stated this all started within a week of the implant.The patient had been ¿nauseated and throwing up and they turned it up and then it was working¿.The patient stated 2-3 weeks ago it was swollen right where the ins was and the doctor said it looked like it had fluid around it but did not know what to do.The patient was advised to take tylenol and put a warm compress on it.They stated the swelling has gone down since then.On the day of the report, the doctor turned the therapy off and the pulsing has stopped.No further patient complications were reported as a result of this event.Additional information was received from a friend or family member of a patient.They reported that the caller said when the hcp increases stim the ins "pulsates" like a punching bag on the patient's ribs and if the hcp decreases stim so the pulsating stops the patient's symptoms return.Caller said right now the patient's settings are below the baseline the hcp uses.Caller said the ins is sitting on top of the patient's ribs and when it pulsates they can see the ins bouncing up and down.Caller said about 20 min after the patient eats there is a hard painful knot under the bottom part of the ins and the pain lasts about an hour.Caller said a sonogram was done which didn't show anything so they have a ct scan scheduled for (b)(6) 2021.Caller said the patient is down to (b)(6).Caller said the patient lost weight about 6 months after the device was implanted.Reviewed device function and adverse events.The caller mentioned they have heard of people throwing up the lead, agent did not ask any other details about this comment.Agent did not ask about the circumstances that led to the reported issue.The patient was redirected to their healthcare provider to further address the issue.

• 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: david gustafson ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635149628
• MDR Report Key: 11556455
• MDR Text Key: 245576043
• Report Number: 3004209178-2021-04772
• 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
• Report Date: 03/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/14/2020
• Device Model Number: 37800
• Device Catalogue Number: 37800
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/19/2021
• Date Device Manufactured: 03/19/2019
• 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