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 Erosion (1750); Internal Organ Perforation (1987); Injury (2348)

Event Date 09/18/2015

Event Type  Injury  

Manufacturer Narrative

Concomitant medical devices: product id: 435135, serial# (b)(4), implanted: (b)(6) 2009, explanted: (b)(6) 2015, product type: lead.Product id: 435135, serial# (b)(4), implanted: (b)(6) 2009, explanted: (b)(6) 2015, product type: lead.Product id: 435135, serial# (b)(4), implanted: (b)(6) 2009, explanted: (b)(6) 2015, product type: lead.(b)(4).

Event Description

The patient was implanted for gastric stimulation.The health care provider (hcp) reported via a manufacturing representative that the leads eroded into the patient's stomach.This occurred during normal use.Both leads were replaced and this resolved the issue.Additional information received from the health care provider (hcp) reported that there was no extrinsic cause determined regarding the lead erosion.The leads were removed with portions of the gastric wound and this was sent to pathology.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

The patient¿s healthcare provider reported via manufacture representative that the patient experienced a lead erosion into the stomach.It was unknown if any environmental/external/patient factors that may have led or contributed to the issue.There were no further complications reported and/or 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 NEUROMODULATION; road 31, km. 24, hm 4; ceiba norte industrial park; minneapolis MN 55432
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 5152781
• MDR Text Key: 28373050
• Report Number: 3004209178-2015-20711
• 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: Followup
• Report Date: 09/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/28/2010
• Device Model Number: 3116
• Device Catalogue Number: 3116
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/13/2017
• Date Device Manufactured: 04/01/2009
• 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: 00042 YR