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

Model Number 3058

Device Problems Migration or Expulsion of Device (1395); Unable to Obtain Readings (1516)

Patient Problem Insufficient Information (4580)

Event Date 10/09/2020

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: product id: 3889-28, lot#: va22zmn, product type: lead.Product id: 3889-28, serial/lot #: (b)(4), ubd: 04-oct-2023, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

The manufacture representative reported that they were at a lead revision on the day of the report where impedance were taken and all unipolar pairs were showing ? even after increasing to 3v, but did not increase the pulse width.It was noted that the patient programmed the unipolar pairs they were not feeling motor or sensory response at 1.5v/3.0v.The implantable neurostimulator (ins) was inside the pocket when the impedance was checked.It was also noted that the healthcare provider did see the blue on the ins when connected.The lead had been taken out and wiped it down before reconnecting to the ins.No symptoms/patient complications were reported.Additional information was received from a manufacturer representative (rep).The rep reported that the reason for the lead revision was a lack of efficacy.According to the physician, the lead was misplaced, explaining the lack of efficacy.Impedances were fine.Device was also fine pre-op.The cause of the unipolar impedances that seemed problematic was not determined.

Event Description

Additional information received reported that the patient was fine and the event was resolved.

Manufacturer Narrative

Continuation of d10: product id: 3889-28, lot# va22zmn, 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.

• 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: 10863322
• MDR Text Key: 218661196
• Report Number: 2182207-2020-01300
• Device Sequence Number: 1
• Product Code: EZW
• Combination Product (y/n): N
• PMA/PMN Number: P970004
• 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: 12/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2020
• 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: 12/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR