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

Model Number 37800

Device Problems Premature Discharge of Battery (1057); Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913)

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

Event Date 02/01/2018

Event Type  malfunction  

Manufacturer Narrative

Analysis results were not available at the time of this report.A follow-up report will be sent when 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) and manufacturer representative regarding a patient with an implantable neurostimulator (ins).It was reported that the ins was never implanted in the patient and never used.It was noted that the device displayed an error message, was defective and stopped working, and therefore they used a different device.No patient symptoms were reported.No further complications were reported/anticipated.

Manufacturer Narrative

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

Event Description

Additional information was received from a manufacturer representative (rep).It was reported that the device was explanted.This contradicts the original report of the device not being implanted.

Manufacturer Narrative

Analysis of the ins (nhx703564h) found insignificant anomalies.The ins output and telemetry were acceptable; however, the battery was near normal battery depletion.There was good, stable output on the electrode pairs the ins had when it was received and a lab functional test determined there was good, stable output on all electrode pairs.There were also no issues when pressing on the ins can.A computer longevity estimate was completed based on the parameters the device had when it was received for analysis.The information obtained from the ins upon receipt indicated the device had reached end of service (eos).If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from a rep.It was reported that the rep didn't recall an unused ins for this patient or surgeon.They reported that the doctor wanted the ins to be analyzed because they thought the battery had depleted too quickly.The rep thought the patient used high settings and it was normal depletion, but the hcp still wanted analysis done.

Event Description

No new information.

Manufacturer Narrative

Removed method codes 23, 26, and 38 and result code 825.Updated conclusion code to 67.Medtronic, inc.(medtronic) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information in the time allotted and has provided as much information as is available to the company as of the submission date this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic or its employees caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".These words are included in the fda 3500a form and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.Medtronic objects to the use of these words and others like it because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.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
• MDR Report Key: 7425898
• MDR Text Key: 105681571
• Report Number: 3004209178-2018-07899
• Device Sequence Number: 1
• Product Code: LNQ
• UDI-Device Identifier: 00643169614246
• UDI-Public: 00643169614246
• Combination Product (y/n): N
• PMA/PMN Number: H990014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/28/2018
• Device Model Number: 37800
• Device Catalogue Number: 37800
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2018
• Initial Date Manufacturer Received: 03/15/2018
• Initial Date FDA Received: 04/12/2018
• Supplement Dates Manufacturer Received: 04/17/2018; 05/16/2018; 01/24/2019
• Supplement Dates FDA Received: 05/11/2018; 05/29/2018; 01/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 31 YR