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

Model Number 37800

Device Problems Migration or Expulsion of Device (1395); Patient Device Interaction Problem (4001)

Patient Problems Foreign Body Reaction (1868); Unspecified Infection (1930); Internal Organ Perforation (1987); Complaint, Ill-Defined (2331)

Event Type  Injury  

Manufacturer Narrative

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

Manufacturer Narrative

Continuation of medical devices: product id 4351-35, serial# (b)(4), implanted: (b)(6) 2015, product type lead.Product id 4351-35, serial# (b)(4), implanted: (b)(6) 2015, product type lead.Information references the main component of the system.Other relevant device(s) are: product id: 4351-35, serial/lot #: (b)(4), ubd: 13-jul-2017, udi#: (b)(4); product id: 4351-35, serial/lot #: (b)(4), ubd: 13-jul-2017, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a consumer regarding a patient.It was reported that the patient was hit in the stomach, right in the gastrostomy tube, which caused the leads to go through the stomach and they got an infection.The infection was confirmed, and the patient received iv antibiotics, as they had a peripherally inserted central catheter (picc) line with harsh medicine.The consumer stated that it was a great device that worked for the patient, but they could not run and play because it was a fragile device.The consumer also reported that the patient had three gastric devices implanted and their body was not accepting the devices.It was noted that the infection occurred maybe three years prior to the date of this report.Additionally, the consumer reported that the patient¿s gastroparesis was getting worse.No further complications were reported or anticipated.Indications for use are gastric stimulation and gastrointestinal/pelvic floor.

• 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: 7902080
• MDR Text Key: 121475893
• Report Number: 3004209178-2018-21348
• 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: consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/14/2016
• Device Model Number: 37800
• Device Catalogue Number: 37800
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/19/2018
• Date Device Manufactured: 06/26/2015
• 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