MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO ENTERRA; INTESTINAL STIMULATOR

Model Number 3116

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

Patient Problems Internal Organ Perforation (1987); Obstruction/Occlusion (2422)

Event Date 07/01/2019

Event Type  Injury  

Manufacturer Narrative

Concomitant medical product: product id: 435135, serial# (b)(4), implanted: (b)(6) 2011, product type: lead; product id: 435135, serial# (b)(4) implanted: (b)(6) 2011, product type: lead.Other relevant device(s) are: product id: 435135, serial/lot #: (b)(4), ubd: 11-feb-2013, udi#: (b)(4); product id: 435135, serial/lot #: (b)(4), ubd: 02-may-2013, udi#: (b)(4).(b)(4) pertain to product id: 435135, serial# (b)(4), product type: lead and product id: 435135, serial# (b)(4), product type: lead.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare professional (hcp) via a manufacturer representative regarding a patient with an implantable neurostimulator (ins) for gastric stimulation.It was reported that there was a bowel obstruction and surgery for bowel perforation was done on (b)(6); however, it was noted that the patient was not reporting any signs or symptoms related to the issue.The plan was to discuss replacing the battery/leads as the battery was now depleted.The issue was not resolved at the time of the report.No further complications were reported/anticipated.

Manufacturer Narrative

Product id 435135, serial# (b)(4), implanted: (b)(6) 2011, product type: lead.Product id 435135, serial# (b)(4), implanted: (b)(6) 2011, 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 no previous history of obstruction and that the surgeon believed the obstruction/perforation was related to the stimulator wires.It was noted that the obstruction/perforation was not related to the patient¿s underlying gastric dysfunction.The patient did well with the surgery and the battery depleted and was replaced; the patient tolerated it well and had not been back for follow-up.No further complications were reported/anticipated.

Manufacturer Narrative

Continuation of concomitant medical products: product id: 435135, serial# (b)(4), implanted: (b)(6) 2011, product type: lead; product id: 435135, serial# (b)(4), implanted: (b)(6) 2011, 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 updated that there was a bowel obstruction and not a perforation.No further complications were reported/anticipated.

• Brand Name: ENTERRA
• Type of Device: INTESTINAL STIMULATOR
• Manufacturer (Section D): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; 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: 8785641
• MDR Text Key: 150859548
• Report Number: 3004209178-2019-13410
• Device Sequence Number: 1
• Product Code: LNQ
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 10/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/28/2012
• Device Model Number: 3116
• Device Catalogue Number: 3116
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/03/2019
• Date Device Manufactured: 11/02/2010
• 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; Other; Required Intervention
• Patient Age: 27 YR