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

Model Number 37800

Device Problems Inappropriate/Inadequate Shock/Stimulation (1574); Patient Device Interaction Problem (4001)

Patient Problems Pain (1994); Loss of consciousness (2418); Ambulation Difficulties (2544); Electric Shock (2554)

Event Date 01/11/2018

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).It was reported that the patient was experiencing shocking pains down their left side close to their lower hip.It was noted that this was gradual and started over the weekend after their surgery, had progressively gotten worse throughout the week, and was the worst pain of the patient¿s life and they ended calling 911 yesterday because it was so bad.The patient went to see their actual surgeon yesterday and it was noted they stated they had never seen this before.The surgeon was reluctant to shut off the ins, but as soon as they did, the pain stopped.It was noted that the patient felt this shocking sensation was always triggered after they ate or drank anything, even just a sip of water, and that the therapy was helping them with their eating; however, now that it¿s off, they were still able to eat some.It was noted that the hcp told the patient that once the device was shut off, it may take a while to actually stop working.The patient¿s indication for use was unknown.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 was doing ok now, they were doing some adjustments now and the patient went in a week ago because the pain was progressively worse; they ended up turning it off until monday.It was noted that the night before last, the patient ate 2 (b)(6) waffles and they determined it was one because the same thing happened again.The patient was frustrated because they were not getting answers and it was the worst pain they had ever had in their life.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 received from a consumer (con).It was reported that the patient sometimes felt electric shocks since they were implanted.Initially, they were so strong that it impeded their day and they had to shut the device off.They confirmed that they put on weight and, at the time of the report, it didn't happen as often.It was noted that they also had a surgery to wrap the stomach.The patient stated it no longer impeded them, but they felt shocks from time to time.

Manufacturer Narrative

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

Event Description

Additional information was received from the patient.They repeated previously reported information.It was reported that they experienced shocks from movement and when eating food.The pain of the shocks was so significant at one point that they could not move and they passed out from the pain.No patient complications were reported as a result of this event.

• 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
• MDR Report Key: 7225702
• MDR Text Key: 98587695
• Report Number: 3004209178-2018-01586
• Device Sequence Number: 1
• Product Code: LNQ
• Combination Product (y/n): N
• PMA/PMN Number: H990014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/14/2019
• Device Model Number: 37800
• Device Catalogue Number: 37800
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 40 YR
• Patient Weight: 52