MAUDE Adverse Event Report: MPRI ENTERRA; INTESTINAL STIMULATOR

Model Number 4351-35

Device Problems Break (1069); Insufficient Information (3190)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/11/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Information was received from a health care professional (hcp) via a manufacturer representative (rep) regarding a patient with an enter gastro lead and an implantable neurostimulator (ins) for unknown indications for use.It was reported by the manufacturer representative (rep) that during the procedure, the ski needle popped/popped off during  handling.The rep noted that it was never implanted and that it was replaced with a new lead.The rep was stated to have had possession of the device and it was noted that the product would be returned for analysis.

Manufacturer Narrative

H3: analysis of the lead 4351-35 (s/n (b)(6)) revealed that the polypropylene suture was cut at 7.5cm from the electrode tip the distal end of the lead.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): MPRI; road 149 km 56.3; villalba PR 00766
• MDR Report Key: 11824154
• MDR Text Key: 250600109
• Report Number: 2649622-2021-09689
• Device Sequence Number: 1
• Product Code: LNQ
• UDI-Device Identifier: 00643169936577
• UDI-Public: 00643169936577
• 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
• Report Date: 08/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/18/2022
• Device Model Number: 4351-35
• Device Catalogue Number: 4351-35
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/26/2021
• Initial Date Manufacturer Received: 05/11/2021
• Initial Date FDA Received: 05/14/2021
• Supplement Dates Manufacturer Received: 08/02/2021
• Supplement Dates FDA Received: 08/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 68 YR