MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. INTERSTIM II; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE

Model Number 3058

Device Problems Display or Visual Feedback Problem (1184); Low impedance (2285); Battery Problem (2885)

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

Event Date 04/18/2018

Event Type  malfunction  

Manufacturer Narrative

Date is estimated; month and year are valid.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare provider (hcp) via a manufacturer representative (rep) regarding a patient who was implanted with an implantable neurostimulator (ins) for fecal incontinence and gastrointestinal/pelvic floor.It was reported that the manufacturer representative was working with a nurse practitioner (np) at the patient's managing healthcare provider's office.The nurse practitioner noticed consistently low longevity estimates for the patient's ins since it was implanted in (b)(6) 2018.The patient had a previous ins from 2013 and had been using 0.7-0.8ma intensity for most of the time they have been using the therapy.When the 2013 ins was changed out, the clinician programmer was showing 0-1 months remaining on the battery life.In (b)(6) 2018, the nurse practitioner noticed that the patient's remaining longevity for the new ins was 0-6 months.Impedances were normal at that time and the patient was using a program that used electrodes 0 and 3 and the patient was still using 0.7-0.8ma for intensity.There was no evidence of a power on reset (por) on the clinician programmer, per the caller.The patient had regular checks of their ins and the longevity continued to show 0-6 months as it did in (b)(6) 2018.In (b)(6) 2019, during a system check, it was noticed that impedance for electrodes 0-3 was <(><<)>50 ohms and the remaining battery life was showing as 1-6 months, but that the remaining battery capacity was 86-100%.The nurse practitioner indicated the patient had been going between programs 1 and4 since (b)(6) 2018 and that both of these programs used 0/3 in programming.As of yesterday, the ins remaining life was showing as 0-1 months per the caller.The manufacturer speculated that the short may have been intermittent and caused the low remaining battery life, but could not explain some of the conflicting information regarding battery capacity and longevity that had been seen with this ins since 2018.Changing programming to something other than 0/3 electrodes was reviewed, as well as information regarding a formal corrective action (fca) on case shorts that occurred with the smart handset and changing settings when trying to determine whether there was an open circuit when testing impedance with a clinician programmer.The caller planned to suggest other programming be used due to the short and low battery level.There were no patient symptoms or further complications reported at this time.

Event Description

Additional information was received from the manufacturer representative (rep).The rep stated that they discussed the impedance issues and decided that to put the patient on a program that does not have a short circuit 50.No further complications were reported.

Manufacturer Narrative

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 PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• MDR Report Key: 11506489
• MDR Text Key: 244810391
• Report Number: 3004209178-2021-04442
• Device Sequence Number: 1
• Product Code: EZW
• UDI-Device Identifier: 00613994913654
• UDI-Public: 00613994913654
• Combination Product (y/n): N
• PMA/PMN Number: P080025
• 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: 04/02/2021

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: 12/14/2018
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/17/2021
• Initial Date FDA Received: 03/17/2021
• Supplement Dates Manufacturer Received: 03/18/2021
• Supplement Dates FDA Received: 04/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 81 YR