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

Model Number 37800

Device Problem Positioning Problem (3009)

Patient Problems Wound Dehiscence (1154); Erosion (1750)

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 4351-35, serial #: (b)(4), implanted: (b)(6) 2018, product type: lead.Product id: 4351-35, serial #: (b)(4), implanted: (b)(6) 2018, product type: lead.Other relevant device(s) are: product id: 4351-35, serial/lot #: (b)(4), ubd: 17-sep-2020, udi: (b)(4).Product id: 4351-35, serial/lot #: (b)(4), ubd: 05-oct-2020, udi: (b)(4).Event problem and evaluation codes: (b)(4).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) for gastric stimulation and gastrointestinal/pelvic floor issues.It was reported that the patient had a previous pocket revision surgery and that the doctor¿s office thought the patient had some type of surgery from an unknown surgeon.At some point, they tried to use a wound vac on the patient around their pocket site.It was noted that now the patient had lead exposure and the entire implant was being removed.The issue was not resolved at the time of the report.No further complications were reported/anticipated.

Manufacturer Narrative

Product id 4351-35, serial# (b)(4), implanted: (b)(6) 2018, product type: lead.Product id 4351-35, serial# (b)(4), implanted: (b)(6) 2018, product type: lead.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from the patient.They stated the ins was removed in (b)(6) 2019 because the incision came open.They stated the lead wires were left implanted.The patient stated they needed an mri so they were advised to consult with an healthcare professional (hcp) about having the leads removed if they needed an mri.No further patient complications were reported as a result of this event.

Manufacturer Narrative

Product analysis #246096235:analysis information (b)(6) 2019 10:08:33 cst pli# 10 product id# 37800 below is unedited, system generated text based on the analysis finding code(s).The returned device was subjected to a series of standard tests that include but is not limited to visual inspection, output and telemetry testing, and functional testing.The implantable neurostimulator (ins) passed functional testing.Concomitant medical products: product id 4351-35, serial# (b)(4), implanted: (b)(6) 2018.Product type lead product id 4351-35, serial# (b)(4), implanted: (b)(6) 2018.Product type lead device evaluated by mfr: analysis of the ins (b)(4) found that it was functionally okay and had insignificant anomalies.Analysis of the lead (b)(4) found that there were no anomalies.Analysis of the lead (b)(4) found that the lead body was stretched but was insignificant.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 PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• MDR Report Key: 8524717
• MDR Text Key: 142273053
• Report Number: 3004209178-2019-07680
• 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: 12/09/2019

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: 01/14/2020
• Device Model Number: 37800
• Device Catalogue Number: 37800
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2019
• Initial Date Manufacturer Received: 04/10/2019
• Initial Date FDA Received: 04/17/2019
• Supplement Dates Manufacturer Received: 07/31/2019; 12/06/2019
• Supplement Dates FDA Received: 08/01/2019; 12/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention