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

Model Number 37800

Device Problems Disconnection (1171); Migration or Expulsion of Device (1395); Unstable (1667)

Patient Problems Wound Dehiscence (1154); Abscess (1690); Unspecified Infection (1930); Pain (1994); Cramp(s) /Muscle Spasm(s) (4521); Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/01/2020

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 patient who was implanted with an implantable neurostimulator (ins) for gastric stimulation.The patient reported they had 2 faulty implants, the second one came detached and flipped sideways, it was noted it had been implanted with mesh.  no other details were provided.No patient symptoms were reported.  see pe (b)(4) : 1st implant faulty.

Event Description

Additional information was received.The patient was asked what caused the device to detach and they reported no falls or trauma.They had severe pain and the stimulator had shifted toward their oblique.They called their doctor and reported severe pain and that something was going on 3 weeks following their revision.The medical assistant stated the doctor said no way it could have moved and the only thing they could offer was a ct scan.They reported that in this 3 week time, the incision was opening up and the patient had an abscess and they called their doctor who said there was no way they had an infection, but they did give the patient antibiotics.They noted being allergic to dermabond, but a different adhesive was used.After that they went to a new healthcare provider who did an x-ray to confirm that the device had ripped through the mesh and made a tunnel down to the abdomen to the oblique area and had shifted about 6-8 inches and flipped forward and made a nest in that area.Their stomach was now concave in that area.The device was not tacked down and the patient was having an internal reaction to the mesh.They had another revision done on (b)(6) 2021 to make a new pouch and put it where it was supposed to be and let it heal.The patient was doing ok at the time, still in a lot of pain but stated this was to be expected due to the extent of the damage and they had been prescribed muscle relaxers for this because they had to dig the stimulator out and they would have severe muscle spasms. .

Manufacturer Narrative

B3: date is approximate.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.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.

• 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 MN 00777
• MDR Report Key: 12010972
• MDR Text Key: 262617570
• Report Number: 2182207-2021-01059
• 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
• Report Date: 06/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/28/2021
• Device Model Number: 37800
• Device Catalogue Number: 37800
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 30 YR
• Patient Weight: 68