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

Model Number 37800

Device Problems Device Operates Differently Than Expected (2913); Impedance Problem (2950)

Patient Problems Nausea (1970); Therapeutic Effects, Unexpected (2099); Therapeutic Response, Decreased (2271)

Event Date 08/25/2015

Event Type  malfunction  

Manufacturer Narrative

Information references the main component of the system and other applicable components are: product id: 4351-35, serial# (b)(4), product type: lead.Product id: 4351-35, serial# (b)(4), product type: lead.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

The consumer reported that the patient's device had not been working like it used for the last 6-9 months prior to the report.It had helped.It was indicated that it had not been working, was not effective, and the resistance had been climbing and was in the red zone.They stated that the patient took more medicine, but was about off of it.It was indicated that the patient had issues with the adjustments not working in 2015.The healthcare provider (hcp) would always adjust it, but they did it wrong.They mentioned that the patient was now seeing a new hcp.It was further reported that it was possible that one or two of the leads migrated 6-9 months ago.They weren't sure if this was correct yet.They did x-rays, but they couldn't tell from the x-rays.It was also noted that the consumer was told that it was going to be a laparoscopic procedure, but it was open.The patient now had a very large incision.There were no further complications reported as a result of this event.The indication for use was gastric stimulation.

Manufacturer Narrative

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

Event Description

Additional information received reported that at each visit resistance increased (450-532-596-612).The patient has not had an egd to evaluate yet.No cause has been determined.It was noted that the patient had 4 active sons and did farm work.The patient¿s kub did not show any kinks or twists.The patient¿s healthcare provider was waiting to egd and revise the patient.It was also reported that the patient¿s stimulation had been adjusted.The patient¿s symptoms had not improved.The patient did not have bloating but was constantly nauseous.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: 6744338
• MDR Text Key: 81491074
• Report Number: 3004209178-2017-15596
• Device Sequence Number: 1
• Product Code: LNQ
• UDI-Device Identifier: 00643169360686
• UDI-Public: 00643169360686
• 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,health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/28/2016
• Device Model Number: 37800
• Device Catalogue Number: 37800
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/27/2017
• Date Device Manufactured: 03/05/2015
• 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: 32 YR