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

Model Number 37800

Device Problems Migration or Expulsion of Device (1395); Insufficient Information (3190)

Patient Problem Erosion (1750)

Event Date 08/20/2019

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 4351-35, serial# unknown, implanted: (b)(6) 2015, explanted: (b)(6) 2019, product type: lead.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a consumer regarding a patient with an implantable neurostimulator (ins) for gastrointestinal/pelvic floor issues.It was reported that the patient had an unrelated surgery on (b)(6) with an endoscope and they determined that the lead had eroded through the patient¿s stomach and the system had failed.The entire system was explanted and a new device was put in.No further complications were reported/anticipated.

Manufacturer Narrative

Concomitant medical products: product id: 4351-35, serial# (b)(4), implanted: (b)(6) 2015, explanted: (b)(6) 2019, product type: lead.Product id: 4351-35, serial# (b)(4), implanted: (b)(6) 2015, explanted: (b)(6) 2019, product type: lead.Analysis results were not available at the time of this report.A follow-up report will be submitted when analysis is completed.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from a healthcare professional (hcp).It was reported that there was a device malfunction and the device was explanted.No further complications were reported/anticipated.

Manufacturer Narrative

Concomitant medical products: product id 4351-35, serial# (b)(4).Implanted: (b)(6) 2015.Explanted: (b)(6) 2019, product type lead product id 4351-35, serial# (b)(4).Implanted: (b)(6) 2015.Explanted: (b)(6) 2019.Product type lead, device evaluated by mfr: analysis of the ins (b)(4).Found no significant anomalies.The ins was subjected to a series of standard tests that included, but was not limited to, visual inspection, output and telemetry testing, and functional testing.The ins passed all functional testing.The leads (b)(4) also found no significant anomalies.The leads were subjected to standard tests that included visual inspection and electrical testing.Electrical testing of the returned lead segment(s) determined that continuity was complete and there were no electrical shorts between the circuits.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: 8951918
• MDR Text Key: 156263680
• Report Number: 3004209178-2019-16725
• Device Sequence Number: 1
• Product Code: LNQ
• UDI-Device Identifier: 00643169360686
• UDI-Public: 00643169360686
• Combination Product (y/n): N
• PMA/PMN Number: H990014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup,Followup
• Report Date: 12/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/28/2016
• Device Model Number: 37800
• Device Catalogue Number: 37800
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/03/2019
• Date Manufacturer Received: 12/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 49 YR