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

Model Number 37800

Device Problems Failure to Deliver Energy (1211); Inappropriate/Inadequate Shock/Stimulation (1574); Unstable (1667); Battery Problem (2885); Insufficient Information (3190)

Patient Problems Therapeutic Effects, Unexpected (2099); Complaint, Ill-Defined (2331); Malaise (2359); Electric Shock (2554)

Event Date 02/01/2019

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 (con) regarding a patient who was implanted with a neurostimulator for gastric stimulation.It was reported that the patient was ¿real sick¿ the week prior to the report.They were sent to a clinic to address these issues and was going to follow-up with a healthcare professional (hcp).No device issues or further complications were reported or anticipated.Additional information was received from a consumer.It was reported that the patient¿s device was not working, and the patient had been having some health issues.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 the patient.It was reported that since implant the patient felt little shocks and the ins was not implanted into their body securely so it was flopping/moving around.The patient stated the ins was floating loose and would pop out of pocket and they would have to push it back in.They stated they knew a few months ago that something was up with the ins because they could not feel the stimulation anymore and got sick back in (b)(6) 2019.The patient was transferred to a new doctor who confirmed the ins was off and showing really low battery.They turned it back on and the patient felt stimulation for a day and a half but then the ins battery died.The patient had the ins replaced and the new ins was secured down with mesh.No further 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
• 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: 8764255
• MDR Text Key: 150138637
• Report Number: 3004209178-2019-12993
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 09/05/2019

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: 04/14/2019
• Device Model Number: 37800
• Device Catalogue Number: 37800
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/25/2019
• Initial Date FDA Received: 07/05/2019
• Supplement Dates Manufacturer Received: 08/15/2019
• Supplement Dates FDA Received: 09/05/2019
• Date Device Manufactured: 10/16/2017
• 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 Outcome(s): Required Intervention
• Patient Age: 38 YR