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

Model Number 37800

Device Problem Impedance Problem (2950)

Patient Problem Vomiting (2144)

Event Date 01/01/2018

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 manufacturer representative regarding a patient with an implantable neurostimulator (ins).It was reported that the impedance reading was out of normal range for electrode 2.The patient had severe vomiting and multiple hospitalizations in the past year.The patient would be referred to a surgeon for possible surgical interventions.The issue was not resolved at the time of the report.No further complications were reported/anticipated.

Manufacturer Narrative

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

Manufacturer Narrative

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

Event Description

Additional information was received from a healthcare professional (hcp) via a manufacturer representative.It was reported that the hcp referred the patient to a surgeon and had no further information.No further complications were reported/anticipated.

• 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: 8853632
• MDR Text Key: 153064260
• Report Number: 3004209178-2019-14843
• 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: 08/23/2019

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: 12/14/2019
• 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: 07/18/2019
• Initial Date FDA Received: 08/01/2019
• Supplement Dates Manufacturer Received: 08/12/2019; 08/12/2019
• Supplement Dates FDA Received: 08/23/2019; 08/23/2019
• Date Device Manufactured: 06/23/2018
• 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): Hospitalization
• Patient Age: 30 YR