MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION INTERSTIM II; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE

Model Number 3058

Device Problems Break (1069); Peeled/Delaminated (1454)

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

Event Date 01/08/2021

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 3889-28, lot#: 022010034, product type: lead.Other relevant device(s) are: product id: 3889-28, serial/lot #: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received a from a manufacturer distributor representative (rep) regarding a patient with an implanted neurostimulator (ins).It was reported that they performed ph phase i lead implantation on (b)(6) 2020.During the second phase of implantation of the stimulator on (b)(6) 2021, it was found that insulation sheath at the contact 0 side of the lead was broken, but it could still be used normally.Didn't replace it with the new lead.The stimulator has been implanted in the body normally.The patient is currently hospitalized for observation.No symptoms were reported.

Manufacturer Narrative

Concomitant products: product id 3889-28 lot# 022010034.Product type 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.

Event Description

Additional information was received from a manufacturer representative (rep).The rep reported that the issue was not resolved, and no further action would be taken.

• Brand Name: INTERSTIM II
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 7000 central ave ne; minneapolis MN 55432
• MDR Report Key: 11195052
• MDR Text Key: 227572355
• Report Number: 2182207-2021-00093
• Device Sequence Number: 1
• Product Code: EZW
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 02/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization