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

Model Number 97810

Device Problems Failure to Interrogate (1332); Delayed Charge Time (2586); Battery Problem (2885); Charging Problem (2892); Communication or Transmission Problem (2896)

Patient Problem Scar Tissue (2060)

Event Date 10/23/2020

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

On (b)(6) 2022 information was received from a patient who was implanted with an implantable neurostimulator (ins) for gastrointestinal/pelvic floor therapy, urinary dysfunction/sacral nerve stim.It was reported that the patient had difficulty charging the ins since first recharge session after implant, patient said that there is less scar tissue now.Patient also emailed that their recharger device was malfunctioning.They had it on the plugged-in docking station for over 48 hours and it still wasn't at full charge; if removed from the docking station or unplugged from the docking station it rapidly loses charge and it takes over an hour to charge the device each week.In contact with patient services the patient stated that about three weeks ago they started to have difficulty with the recharger said that it is taking longer to recharge and has been plugged in for longer than 48 hours and they have tried different outlets.When asked, patient said that they keep recharger in the dock when not in use however they do not have the dock plugged in.Reviewed troubleshooting regarding dock and that appeared to be fine.Patient said that recharger had all green lights on the battery now when not in the dock.Patient turned on and recharger is working.Patient plans to keep recharger in plugged in dock in between uses and monitor recharger battery and provide update.The following troubleshooting steps were performed: reset the recharger, located the ins by looking for incision and/or palpating the ins, patient said doesn't feel the whole outline only feels a ridge about half an inch long.Next patient was instructed to place recharger over ins site before turning recharger on, then turn recharger on.Patient repositioned the recharger several times, and recommended patient lean forward while sitting to optimize ins position.The troubleshooting steps that were taken on the call resolved the issue.Patient connected and ins battery at 50%.Patient said typically recharges every week.Patient plans to follow these steps and monitor and if they continue to experience to schedule appointment with hcp to check ins placement.Patient said they have moved and haven't found a urologist yet; they were sent physician listings.On (b)(6) 2024 additional information was received from the patient.They reported that their implant no longer communicates with the charger or handset and that it's most likely dead since they haven't been able to charge it for 5 weeks.They need an mri and are wondering if they still need to put the device into mri mode even though the battery is dead.Their doctor has recommended a replacement.They reiterated that they've had issues charging their device since it was first implanted.They were told they were doing everything correctly and they didn't know why they were having difficulty connecting.It's been degrading since (b)(6) 2020, and now it appears to be dead.Their doctor couldn't even find the device with their handset.

• 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: 18739888
• MDR Text Key: 336881415
• Report Number: 3004209178-2024-05232
• Device Sequence Number: 1
• Product Code: EZW
• 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: Other
• Type of Report: Initial
• Report Date: 02/20/2024

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: 10/14/2021
• Device Model Number: 97810
• Device Catalogue Number: 97810
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/15/2024
• Initial Date FDA Received: 02/20/2024
• Date Device Manufactured: 04/17/2020
• 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
• Treatment: "SEE H11...."
• Patient Age: 39 YR
• Patient Sex: Female