MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION ENTERRA; INTESTINAL STIMULATOR

Model Number 435135

Device Problems High impedance (1291); Device Operates Differently Than Expected (2913)

Patient Problems Adhesion(s) (1695); Micturition Urgency (1871); Pain (1994); Therapeutic Effects, Unexpected (2099); Urinary Retention (2119); Hernia (2240); Urinary Frequency (2275); Prolapse (2475); No Known Impact Or Consequence To Patient (2692); Constipation (3274)

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

The manufacturer representative (rep) reported that the patient needed to have their leads tightened.There were no reported symptoms.It was first noticed that the leads needed tightening on (b)(6) 2016.The indication-for-use (ifu) was gastric and gastrointestinal/pelvic floor.No outcome, cause, or troubleshooting performed were reported regarding this event.Further follow-up is being conducted to obtain this information.If additional information is received, a follow-up report will be sent.Refer to regulatory report #3007566237-2016-00489 for information on the patient's other lead.

Event Description

Additional information received from the manufacturer representative (rep) on (b)(6) 2016 reported that the patient had a previous surgery on the device.The patient presented to the health care professional (hcp) on 2016-01-06 with the following findings.The local hcp who checked the device told the patient that her impedance was 1800 ohms.She also had some protrusion from her anal area and pelvic pain.There was some protrusion from her anal area with bowel movements.The patient was told she had a hernia at the superior portion of the incision and a umbilicus on ct.The impression at the hcp was office: two or more chronic illnesses, poor controlled gastroparesis, and high impedance indicating disconnected or broken lead or loose retention screw.The patient had constipation by delayed colonic transit, an haugl1/o total colectomy, frequency-urgency syndrome, urinary retention, rectocele, and pelvic relaxation due to rectocele.The results of the testing and interrogation of the gastric electrical stimulator: ges settings - arrival departure, voltage - 5 volts, pulse width - 450 microseconds, rate - 55, cycle on - 2, cycle off - 3, and impedance - 7048 ohms.The leads were replaced on 2016-01-08 and the appropriate impedance was achieved.Impedance was in range at completion of the case (429 ohms).During the surgery, there were extensive adhesions of the abdomen.There was successful placement of a gastric pacer and leads.They also repaired the incisional hernia during the replacement surgery.

Manufacturer Narrative

Patient code of (b)(6) no longer applies.This medical device report is being resubmitted to the emdr system due to a connection error within the emdr system.The event was previously reported to the emdr portal and an acknowledgement 3 received, but the connection error prevented the emdr system from documenting the report.The report number in this report is the same number as the impacted report that has the connection issue.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.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 NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• MDR Report Key: 5399783
• MDR Text Key: 37241595
• Report Number: 3007566237-2016-00490
• Device Sequence Number: 1
• Product Code: LNQ
• 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
• Type of Report: Initial,Followup
• Report Date: 06/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/09/2007
• Device Model Number: 435135
• Device Catalogue Number: 435135
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/09/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 00046 YR