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

Model Number 3058

Device Problem Pocket Stimulation (1463)

Patient Problems Pain (1994); Anxiety (2328)

Event Date 06/20/2022

Event Type  malfunction  

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

Information was received from a patient who was implanted with an implantable neurostimulator (ins) for urinary/bowel dysfunction and urge incontinence.It was reported that the patient reported the therapy didn't seem to be working as well as they thought it would (since implant, they hadn't been getting a 50% or greater reduction in their symptoms,) and the patient called to inquire about making a change to their setting and to inquire about their programs.  the patient's therapy was on, on program 2 at 2.6 v.The patient stated they reported to a manufacturer representative (rep) that the therapy wasn't helping "a couple days" after their implant and the rep had the patient go from program 1 to program 2 at that time.The patient stated since then, they've been coming back on their own to their settings and increasing the stimulation on program 2.At the time of the call, the patient stated they couldn't increase past 2.6 v because it was pretty sore at their implant site because the stimulation was too high.The patient stated as they were gradually increasing on program 2, they were starting to feel the stimulation at their implant site and that now it was pretty sore.Patient services reviewed stimulation expectations with the patient and the patient then switched to program 3 and they increas ed the stimulation to a level where they felt it comfortably in their bike seat region.The patient stated they were going to monitor their symptoms now that a change had been made and that they would reach out to their hcp about their symptom concerns if the issue did not resolve.The patient's relevant medical history included the patient stated for their trial, they had it up to "7," which was pretty high for a stimulation setting but it went very well.Additional information was received on 2022-aug-15 where the patient indicated they are still not having great success with the implant. the caller indicates that theystarted to get relief but then it began to decline in mid-july.Caller has tried increasing intensity and has tried some programs.Reviewed with the caller to try the remaining programs and to continue keeping a log of symptoms.The caller indicates that one program made them feel anxious and nervous but it resolved when decreased and one program was felt in the ins pocket, so they changed to a different program to resolve that.The caller also noted that they have been working with an endocrinologist for diabetes and were told that could impact symptoms as well.Patient services reviewed that some medications and diet can also impact.The caller asked how long to remain on a program and reviewed that direction should come from the hcp.The caller will continue to evaluate available programs and keep track.Additional information was received from the patient.They reported that the cause of the pain at the ins is unknown.The patient also indicated that it is unknown if the issue is resolved.

• Brand Name: INTERSTIM II
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCON
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 15431145
• MDR Text Key: 306253746
• Report Number: 3004209178-2022-11890
• Device Sequence Number: 1
• Product Code: EZW
• UDI-Device Identifier: 00763000449711
• UDI-Public: 00763000449711
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P080025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/15/2022

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: 04/28/2023
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/16/2022
• Initial Date FDA Received: 09/15/2022
• Date Device Manufactured: 11/09/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Sex: Male