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

Model Number 37800

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Pain (1994)

Event Date 03/27/2019

Event Type  Injury  

Manufacturer Narrative

Analysis results were not available at the time of this report.An additional report will be sent once analysis is completed.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a consumer (con) via a manufacturer representative (rep) regarding a patient who was implanted with a neurostimulator for gastric stimulation.It was reported that the device was moving in the pocket causing pain.There were no factors noted that could have led or contributed to the issue.The device was checked and was functioning properly.The patient was getting a revision and replacement on (b)(6) 2019.It was unknown if the issue was resolved at the time of the report.No further complications were reported or anticipated.

Manufacturer Narrative

Analysis of the ins ((b)(4)) found the ins was functionally okay; there were insignificant anomalies.The ins was subjected to a series of standard tests that include, but is not limited to, visual inspection, output and telemetry testing, and functional testing.The ins passed functional testing.If information is provided in the future, a supplemental report will be issued.

• 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: 8486505
• MDR Text Key: 141022123
• Report Number: 3004209178-2019-06775
• 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,consum
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 06/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/14/2020
• Device Model Number: 37800
• Device Catalogue Number: 37800
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2019
• Date Manufacturer Received: 05/29/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/20/2018
• 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: 46 YR
• Patient Weight: 61