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 Problem Pain (1994)

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 435135, serial#: (b)(4), implanted: (b)(6) 2006, explanted: (b)(6) 2019, product type: lead.Product id: 435135, serial#: (b)(4), implanted: (b)(6) 2006, explanted: (b)(6) 2019, product type: lead.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a materials manager at a hospital via a manufacturer representative (rep) regarding a patient with an implantable neurostimulator (ins) for the treatment of gastric stimulation.It was reported that the patient had pain at the pocket site so the device system was removed.No external issues were noted other than pain at the pocket site.The issue was resolved at the time of the report.No further patient complications were reported as a result of this event.

• 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: 9446479
• MDR Text Key: 180709519
• Report Number: 3004209178-2019-23525
• 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: company representative,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/10/2019

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: 12/28/2017
• Device Model Number: 37800
• Device Catalogue Number: 37800
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/06/2019
• Initial Date FDA Received: 12/10/2019
• Date Device Manufactured: 07/06/2016
• 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): Required Intervention
• Patient Age: 57 YR