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

Model Number 37800

Device Problems Migration or Expulsion of Device (1395); Impedance Problem (2950)

Patient Problems Nausea (1970); Paresis (1998); Therapeutic Effects, Unexpected (2099); Vomiting (2144); Therapeutic Response, Decreased (2271)

Event Date 08/24/2018

Event Type  Injury  

Manufacturer Narrative

Other relevant device(s) are: product id: 4351, serial/lot #: (b)(4), product id: 4351-35, serial/lot #: (b)(4), ubd: 05-may-2018, udi#: (b)(4).(b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from an healthcare professional (hcp) regarding a patient with an implantable neurostimulator (ins) for gastric stimulation.It was reported the hcp explanted the enterra lead due to migration.The hcp stated the leads migrated and were explanted on (b)(6) 2018 because the patient didn¿t have improvement, and the stimulator was still in the patient.The hcp stated the surgeon wanted to return the leads.It was noted the patient was ¿scoped¿ on (b)(6) 2018, but that migration was observed on (b)(6) 2018.There were no further complications that have been reported as a result of this event.

Manufacturer Narrative

Concomitant medical products.Product id 4351-35 serial# (b)(4) implanted: -(b)(6)2016, explanted: (b)(6)-2018,product type lead product id 4351-35, serial# (b)(4), implanted: (b)(6)2016, explanted: -(b)(6) 2018, product type lead (b)(4).Pertain to product id 4351-35, serial# (b)(4), product type lead and product id 4351-35, serial# (b)(4), product type lead.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from a healthcare professional (hcp).It was reported that the patient had an improvement of symptoms, but now had a recurrence of symptoms with an increase of impedance.The preoperative diagnoses were gastroparesis, chronic nausea and vomiting, and a migration of the leads.It was noted that the procedures involved included robotic lead replacement, gastric stimulator pocket revision, esophagogastroduodenoscopy, and reprogramming.During the procedure, the leads were identified and dissected free from the stomach, cut from the button and the button was removed, and the leads were removed from the stomach and abdomen.Two new leads were placed into position, and the impedance was tested and found to be 528.The new leads were connected to the battery, the battery was sutured into the pocket, and all incisions were closed.The battery was turned on and the impedance was found to be 447 and the voltage was 2.2.It was noted that the patient tolerated the procedure well.No further complications were report ed/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: 7922417
• MDR Text Key: 122187538
• Report Number: 3004209178-2018-21911
• Device Sequence Number: 1
• Product Code: LNQ
• UDI-Device Identifier: 00643169360686
• UDI-Public: 00643169360686
• 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: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/18/2018

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: 10/28/2017
• Device Model Number: 37800
• Device Catalogue Number: 37800
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/07/2018
• Initial Date FDA Received: 10/01/2018
• Supplement Dates Manufacturer Received: 10/03/2018
• Supplement Dates FDA Received: 10/18/2018
• Date Device Manufactured: 05/07/2016
• 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: 70 YR
• Patient Weight: 91