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

Model Number 37800

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Adhesion(s) (1695); Erosion (1750); Bruise/Contusion (1754); Complaint, Ill-Defined (2331)

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 435135, serial#: (b)(4), implanted: (b)(6) 2016, explanted: (b)(6) 2018, product type: lead.Product id: 435135, serial#: (b)(4), implanted: (b)(6) 2016, explanted: (b)(6) 2018, product type: lead.Other relevant device(s) are: product id: 435135, serial/lot #: (b)(4), ubd: 09-feb-2011, udi#: (b)(4) ; product id: 435135, serial/lot #: (b)(4), ubd: 11-feb-2011, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare professional (hcp) regarding a patient who was implanted with a neurostimulator for gastric stimulation.It was reported that the diagnosis was lead erosion and there was a procedure done on (b)(6) 2018.The gastric lead eroded into the gastric lumen.They had eroded not only into the patient¿s stomach, but also into their small intestine.During the surgery to remove the devices, the hcp found the adhesions were extremely dense and the abdominal wall was either ossified to some degree or there was a hernia mesh, but it was difficult to tell.The hcp had to make a couple of enterotomies and they noted it was basically impossible to not injure the bowel wall peeling it off of the abdominal wall due to the dense nature of the adhesions.It was noted that all adhesions were related to the small bowel and stomach.The hcp cut and removed a portion of the leads from the abdomen and from the pocket and it was apparent that the leads had eroded into the small bowel, which had actually grown around the leads leading down to the stomach.The small bowel was carefully peeled from the stomach in the leads and the leads were isola ted down to their entry point, where the hcp was able to pull the leads and remove them in their entirety.There were multiple enterotomies, involving only one single loop of the small bowel.The hcp noted some bruising on the inferior limb of the small bowel.After the surgery, the small bowel was examined and there was no evidence of any other full-thickness defects.The leads and gastric generator were explanted.No further complications were reported or 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: 9197063
• MDR Text Key: 166013894
• Report Number: 3004209178-2019-19734
• 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: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/16/2019

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/28/2018
• 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: 10/08/2019
• Initial Date FDA Received: 10/16/2019
• Date Device Manufactured: 08/13/2016
• 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): Life Threatening