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

Model Number 37800

Device Problems Break (1069); Difficult to Remove (1528); Device Operates Differently Than Expected (2913)

Patient Problem Paresis (1998)

Event Date 04/12/2018

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 4351, lot/serial#: unknown, product type: lead.(b)(4) pertain to product id: 37800, serial#: (b)(4), product type: intestinal stimulator.(b)(4) pertain to product id: 4351, serial#: unknown, product type: lead.(b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from healthcare professional (hcp) regarding a patient with an implantable neurostimulator (ins) for gastric stimulation.It was reported that the patient had gastroparesis and had a procedure for the removal of non-connected leads that were left by the previous hcp, revision of operable leads with replacement of one gastric seromuscular lead, and generator exchange.The following was reported to have been observed and occurred during the procedure: it was noted that there were dense adhesions which significantly added to the difficulty of the procedure.The adhesions were to the stomach, liver, abdominal wall, and the two sets of leads.Once the stomach was somewhat mobilized, the two sets of leads were dissected free of the surrounding adhesions to where they entered the generator pocket, the pocket located on the right side of the abdomen was opened using scalpel, cautery was used to dissect the generator, and both sets of leads were dissected free of the pocket.It was noted that they were encased in dense adhesions and were reduced into the abdomen, which required opening of the fascia underneath the generator pocket.Once in the abdomen, the leads not connected to the generator were removed from the stomach wall and the leads currently connected to the generator were freed from the adhesions and moved to the left side of the abdomen.It was noted that during this process, one lead was injured and was therefore removed from the stomach.A new lead was placed in the seromuscular layer of the stomach about a centimeter proximal to the lead in good position.An egd was done to confirm that all repairs were not leaking by insufflating the stomach under warm saline and assessing for bubbling.The leads were noted to not be within the stomach lumen, a new generator pocket was created on the left side of the abdomen, and the two leads were brought out into this pocket and reconnected to the new generator.It was noted that the impedance was good and the new generator was programmed with the following settings: current 10, volts: 4.0, pw 330, rate 40, on 4 seconds and off 1 second.The patient tolerated the procedure well and was taken to recovery in good condition.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: 7637692
• MDR Text Key: 112316471
• Report Number: 3004209178-2018-14306
• 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: Physician
• Type of Report: Initial
• Report Date: 06/26/2018

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: 08/28/2016
• 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: 06/13/2018
• Initial Date FDA Received: 06/26/2018
• Date Device Manufactured: 03/13/2015
• 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 Outcome(s): Required Intervention
• Patient Age: 41 YR
• Patient Weight: 81