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

Model Number 37800

Device Problem Battery Problem (2885)

Patient Problems Nausea (1970); Vomiting (2144)

Event Type  Injury  

Manufacturer Narrative

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 manufacture representative (rep) regarding a patient with an implantable neurostimulator (ins).It was reported the hcp stated the patient was in the hospital for increased nausea and vomiting.The patient had previously complained that he didn¿t believe his device was working.The hcp stated he turned off the device to show the patient it was working.The hcp stated he turned it back on a few months ago and when he checked the battery on (b)(6) it was dead.The hcp planned to replace the battery on (b)(6) 2018.The hcp issues stated the patient had some psychiatric issues.The hcp noted it was unknown if there were any environmental, external, or patient factors that may have led or contributed to the issue.The rep noted the issue was not resolved at the time of the report.There were no further complications that have been reported as a result of this event.

Manufacturer Narrative

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

Event Description

Additional information form the manufacture representative (rep) on (b)(6) reported the device was discarded.There were no further complications that have been reported as a result of this event.

Manufacturer Narrative

Review of this mdr and/or additional information received shows that there is no information to reasonably suggest that the device in this report may have caused or contributed to a death or serious injury or that the device in this report has malfunctioned.Therefore, this event did not and does not meet the reporting requirements stipulated in 21 cfr 803.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: 7996251
• MDR Text Key: 124728922
• Report Number: 3004209178-2018-23720
• 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,Followup
• Report Date: 03/01/2019

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/14/2018
• Device Model Number: 37800
• Device Catalogue Number: 37800
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/17/2018
• Initial Date FDA Received: 10/23/2018
• Supplement Dates Manufacturer Received: 11/30/2018; 03/01/2019
• Supplement Dates FDA Received: 12/06/2018; 03/01/2019
• Date Device Manufactured: 09/20/2016
• 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): Hospitalization