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

Model Number 3116

Device Problems Migration or Expulsion of Device (1395); Electromagnetic Compatibility Problem (2927); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Staphylococcus Aureus (2058); Sepsis (2067)

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 435135, serial# (b)(4), product type: lead.Product id: 435135, serial# (b)(4), product type: lead.Other relevant device(s) are: product id: 435135, serial/lot #: ,(b)(4) ubd: 12-jul-2013, udi#: (b)(4); product id: 435135, serial/lot #: (b)(4), ubd: 12-jul-2013, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a patient with an implantable neurostimulator (ins) for the treatment of gastrointestinal/pelvic floor and gastric stimulation.It was reported that the patient was diagnosed with severe sepsis and a (b)(6) infection due to unrelated medical procedures and had to have their ins removed when the doctors gutted their abdominal cavity.They also stated two of their leads got pulled during this unrelated procedure.The patient stated they asked for their second ins to be replaced in 2017 but does not currently have an implanted device.No further patient complications were reported as a result of this event.

• 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: 8955911
• MDR Text Key: 156407541
• Report Number: 3004209178-2019-16817
• 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: consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/14/2012
• Device Model Number: 3116
• Device Catalogue Number: 3116
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/08/2019
• Date Device Manufactured: 05/23/2011
• 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