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

Model Number 37800

Device Problem High impedance (1291)

Patient Problems Erythema (1840); Gastritis (1874); Pain (1994); Depression (2361)

Event Date 03/08/2019

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 there was a lead issue.The rep noted the patient saw the hcp on march 8th and the patient had a new right sided pain and worsening depression.It was noted the patient¿s impedance was out of range, c & 2 at 444, c & 3 at 4212, 2 & 3 at 4660.The hcp planned on an abdominal x-ray, esophagogastroduodenoscopy (egd) and a return to clinic.It was unknown if there was any environmental, external, or patient factors that may have led or contributed to the issue.It was unknown if there was any interventions or actions taken to resolve the issue.The issue was not resolved at the time of the report.It was noted no surgical intervention taken or planned.It was also noted the patient had a history of depression.The patient was listed as alive with no injury 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 was received from a healthcare professional (hcp).The abdominal x-ray revealed no physical defect in the gastric pacer wires.The egd revealed a normal esophagus, erythema duodenum, gastritis, and visible suture in the pre-pyloric region.No further complications were reported/anticipated.

Event Description

Additional information was received from a healthcare professional (hcp) via manufacturer representative.It was reported that the patient had their battery changed on (b)(6) 2019.The impedance was approximately 1300 with lead c3 at over 900, while c2 was 400.The hcp swapped the battery out due to the patient¿s high settings of 6.5 volts, 28 rate, and on time of 4 sec and off 1 sec.It was noted that it had been 16 months since the patient¿s last implant and at those settings, the battery usually lasted 18 months.The final impedance was 499 after securing the leads to the new battery.No further complications were reported/anticipated.

Manufacturer Narrative

Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.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 and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee 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 regulatory reporting.Medtronic objects to the use of these words and others like them 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.

• 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: 8413295
• MDR Text Key: 138574479
• Report Number: 3004209178-2019-05058
• 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
• Report Date: 05/14/2019

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: 01/28/2019
• Device Model Number: 37800
• Device Catalogue Number: 37800
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/08/2019
• Initial Date FDA Received: 03/12/2019
• Supplement Dates Manufacturer Received: 03/28/2019; 04/30/2019
• Supplement Dates FDA Received: 04/11/2019; 05/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR
• Patient Weight: 107