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

Model Number 37800

Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problems Pain (1994); Electric Shock (2554)

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 friend/family member regarding a patient who was implanted with an implantable neurostimulator (ins) for gastroparesis - enterra stimulation.It was reported that  pt has been having a lot of issues with their device.Caller clarified the problems pt has been having is that sometimes pt will get "little shocks here and there" and has been having some pain on their "left side where it is" (agent not clear what caller was referring to by this statement).The caller stated sometimes pt experiences shooting pain and sometimes they experience intermittent pain.The caller stated they are concerned that something is going on and want to figure it out since pt has had no maintenance or follow-up with the device.Caller stated pt has not been available to go to the hcp for about a year due to "dealing with some legal issues"(unrelated).Caller stated pt is planning to follow up with pt's gi specialist on march 8th but stated this appt.Has not been confirmed yet.Reviewed role of patient services and process to request rep at appt.Caller stated it's "been kind of ongoing" and stated they think it's been getting worse because pt has been going back to the hospital more frequently.The caller stated pt went to the hospital last night due to pain in the left side of pt's stomach that first started as "normal pain" then stated it started "getting tougher and tougher" and pt's left side of stomach started to feel really hard.Caller stated pt was also in the hospital 2 weeks ago, and stated they think 3 weeks prior to that.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.No further complications were reported/anticipated at this time.

• 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: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 13672714
• MDR Text Key: 289999109
• Report Number: 3004209178-2022-02846
• 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: 03/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/14/2021
• Device Model Number: 37800
• Device Catalogue Number: 37800
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/28/2022
• Date Device Manufactured: 07/17/2019
• 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
• Patient Outcome(s): Required Intervention
• Patient Sex: Male