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

Model Number 3058

Device Problems Intermittent Continuity (1121); Display or Visual Feedback Problem (1184); Failure to Deliver Energy (1211); Energy Output Problem (1431); Device Difficult to Program or Calibrate (1496); Data Problem (3196)

Patient Problems Device Overstimulation of Tissue (1991); Therapeutic Response, Decreased (2271); Complaint, Ill-Defined (2331); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 04/24/2020

Event Type  malfunction  

Manufacturer Narrative

Date of event: date is estimated; year is valid.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a patient with an implanted neurostimulator (ins) for urinary dysfunction/sacral nerve stimulation and gastrointestinal/pelvic floor therapy.They reported that about three months ago, the external device was not adjusting.The patient was supposed to see their healthcare provider, however, due to the covid-19 pandemic, their appointment was cancelled.It was reported that about three weeks ago, the patient experienced a return of symptoms.The caller was able to connect the programmer to the patient's implant and made an adjustment on the call.The patient programmer was functioning as designed.The patient noted they would monitor their symptoms for at least one to two days and make adjustments as necessary.Additional information was received from the patient.They reported that they ¿cannot see the screen,¿ and they ¿press the button but the number indicates no change.¿ they also reported that when the feel it, they ¿buckle because the change is not gradual, but it jumps to a higher setting and they cannot take it.¿ the patient stated that they think they need a new controller.

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.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 the patient.They reported that their programmer was still in use and that the cause of their not being able to see the screen was not determined.The patient stated ¿i don¿t know.¿ in response to the inquiry for what steps had been or would be taken to resolve this issue, the patient replied ¿none, yet,¿ and in response to if the issue had been resolved, they replied ¿not yet.¿ in response to the inquiry for if the cause of the numbers not indicating a change when the patient pressed the button had been determined, the patient replied ¿yes,¿ that what most likely caused or contributed to the issue was ¿error, program would not display on monitor.¿ in response to the inquiry for what steps had been or would be taken to resolve the issue, the patient replied ¿batteries turned off, taken out, date? date?¿ the patient replied that this issue had not yet been resolved.In response to the inquiry for if the cause of the change not being gradual, but it jumping to a higher setting and making the patient buckle had been determined, the patient replied ¿no,¿ and that what most likely caused or contributed to the issue was ¿error on device.¿ in response to the inquiry for what steps were or would be taken to resolve this issue, the patient replied ¿nothing.Screen is blank.¿ no further complications were reported at this time.

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.

Event Description

Additional information was received from the patient.They called back reporting that they continued to have therapy concerns.The patient stated they thought the interstim was shutting off because they would go a couple days experiencing baseline symptoms and then when their spouse would check the device with the programmer, the patient would feel a surge.It was reviewed with the patient how to check the therapy status in order to tell if the therapy was actually off or if it felt like it was off.It was noted that presently, the lightening bolt icon was appearing indicating that the therapy was on.It was reviewed with the patient how to change programs and it was recommended that the patient monitor their symptoms.It was also reviewed the option to try different programs and if not resolved the patient should follow up with their managing health care professional (hcp).General use of the 3037 programmer was also reviewed.

• 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: 10597458
• MDR Text Key: 208942826
• Report Number: 3004209178-2020-16850
• Device Sequence Number: 1
• Product Code: EZW
• UDI-Device Identifier: 00613994913654
• UDI-Public: 00613994913654
• Combination Product (y/n): N
• PMA/PMN Number: P970004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup,Followup
• Report Date: 06/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/14/2020
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/21/2020
• Initial Date FDA Received: 09/28/2020
• Supplement Dates Manufacturer Received: 01/04/2021; 05/27/2021
• Supplement Dates FDA Received: 01/13/2021; 06/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 58 YR
• Patient Weight: 95