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

Model Number 97810

Device Problems Unintended Collision (1429); Unstable (1667); Charging Problem (2892); Communication or Transmission Problem (2896); Insufficient Information (3190)

Patient Problems Bruise/Contusion (1754); Discomfort (2330); Insufficient Information (4580)

Event Date 10/28/2021

Event Type  malfunction  

Manufacturer Narrative

Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

Event Description

Information was received from a patient who was implanted with an implantable neurostimulator (ins) for urinary dysfunction/sacral nerve stim and gastrointestinal/ pelvic floor.It was reported that the patient(pt) reported therapy has "never really worked properly" since date of implant.Pt stated they worked with medtronic rep and tried "certain things" but it didn't work.Pt stated rep advised pt turn off ins to "reset/regroup" and see if when pt turned ins back on if starting over would help pt get better results.Pt stated they did that and they have gone through all 7 programs and adjusted settings but that hasn't seemed to work.Pt stated they would "reset" everything and when they would go back to check their settings they didn't think their settings were staying at what they changed them to.Agent inquired about when this occurred and pt stated it is "hard to put a time on it".Pt also stated they have tried decreasing stimulation.Reviewed therapy overview.Agent tried to inquire about steps pt is taking once they adjust therapy settings and pt was unable to provide steps.Agent walked pt through checking therapy settings and pt confirmed on the call that therapy was on at program 6.Pt increased stimulation and stated they were feeling a sensation in their testicles, but stated it was "not the same as before".Pt stated they "think" they were feeling this sensation in their bike seat area and confirmed it felt "ok".Pt wanted to leave therapy at 1.8 and will decrease stimulation if becomes uncomfortable at any point.Agent did not ask about the circumstances that led to the reported issue.The issue was not resolved through troubleshooting.Patient will maintain stimulation level and will continue to track symptoms.No further complications were reported at this time.Additional information was received from the patient.It was reported that they had called back and said the adjustment from friday didn't work.He was on program 6 at 1.8 and wanted to know what to do next.Prior to this he ran through all the programs at 0.8.Patient is using 6 depends a day to manage his symptoms.Helped patient check his settings.On the call he increased his stimulation on the current program.Patient is going to monitor his symptoms for a couple days and see if his symptoms improve.On 2022-sep-09, it was reported that the patient said that he raised it to 2.3 and was too much and brought it down to 2.2and feels comfortable.He wanted to know if he should leave it there.I told him to keep it there for a couple days and see if his symptoms improve.Additional information was received from the patient.They reported that they had a fall off of their exercise bike on the 9th of october.Pt states they haven't really noticed a change in therapy but then stating they have had some issues in the past but that it's nothing new.Pt states they landed really hard on the their back and on the stimulator.Pt inquired if there is anything that they should do.Agent recommended getting device checked just to verify everything looks ok.Pt states they do have a call in to their doctor already.Additional information was received from the patient and their spouse.Patient reiterated that the therapy hadn't been helping their symptoms and they hadn't used the ins in awhile and they were trying to charge the ins but having a difficult time in doing so.Patient services tried to help the patient start a charging session and the patient received an open loop charging screen of 1, 3, 18 but then the recharger went back to searching.The spouse stated they could feel the scar and confirmed the patient was sitting in a metal wheelchair and also confirmed that the patient had had the communicator in their hand and it was on and flashing the blue light.Patient services reviewed with the caller to turn the communicator off because that would certainly interfere with charging and also suggested the metal of the wheelchair could be impacting the recharger's ability to connect to charge the ins.The caller helped the patient shift to a rocking chair and while they were moving the patient, patient services heard the recharger make multiple d escending tones.When the patient's spouse had the patient situated they saw that the recharger was inactive on the recharger application.The caller turned the recharger back on and placed the recharger over the ins.The recharger kept searching.The caller stated that the ins felt tilted towards the inside of the patient's back.Patient services reviewed to try to position the recharger over the part of the ins that was closest to the surface of the skin.The caller received a 1707 service code and then dismissed it.They received another 1707 service code and dismissed it.The recharger then made an ascending tone that it connected to charge the ins and the caller saw the patient's ins was at 10% charge and then the recharger went back to searching.The caller stated they were in a very uncomfortable position trying to hold the recharger in place and stated they may have shifted the recharger.The caller also admitted that the patient had fallen fairly recently (a couple of days ago) and the patient's back had been all bruised.The caller tried to connect to charge the ins again and got another 1707 service code and then saw the recharger was inactive.Caller stated they were going to try to charge the patient with the patient laying down or on the bed and stated they may call back for assistance.Patient services reviewed that with the fall, the tilted ins and the 1707 codes they might also want to reach out to the patient's hcp to check the implanted system.The caller stated they would try another charging session with the patient laying down and they may call back but stated they would reach out to the patient's managing health care provider (hcp) to check the implanted system.

• Brand Name: INTERSTIM
• 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: 18956641
• MDR Text Key: 338686838
• Report Number: 3004209178-2024-07586
• Device Sequence Number: 1
• Product Code: EZW
• UDI-Device Identifier: 00763000203849
• UDI-Public: 00763000203849
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P970004
• 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: 03/21/2024

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: 01/14/2023
• Device Model Number: 97810
• Device Catalogue Number: 97810
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/23/2024
• Initial Date FDA Received: 03/21/2024
• Date Device Manufactured: 07/17/2021
• 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: 78 YR
• Patient Sex: Male