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

Model Number 37800

Device Problems Failure to Interrogate (1332); Communication or Transmission Problem (2896)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/10/2020

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: product id: neu_wrench_acc, lot#: unknown, product type: accessory.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 healthcare professional (hcp) via a manufacturer representative (rep) regarding a patient who was implanted with a neurostimulator for gastric stimulation.It was reported that the battery would not connect to the clinician programmer during the procedure.The hcp turned the programmer off and restarted it and attempted to connect to the battery multiple times but was not able to.The hcp also removed the battery, cleaned the leads, and tried to connect again.The hcp decided to get a new battery and was able to connect to a different battery and move forward with the implant.The issue was noted to be resolved.No symptoms or further complications were reported or anticipated.

Manufacturer Narrative

Product id neu_wrench_acc, lot# unknown.Product type accessory.Analysis of the ins ((b)(4)) found no 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 all 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: david gustafson ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635149628
• MDR Report Key: 9647362
• MDR Text Key: 177054038
• Report Number: 3004209178-2020-02174
• 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,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/28/2021
• Device Model Number: 37800
• Device Catalogue Number: 37800
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/13/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/10/2019
• 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 Age: 39 YR