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

Model Number 97810

Device Problems Overheating of Device (1437); Unstable (1667); Delayed Charge Time (2586); Charging Problem (2892); Communication or Transmission Problem (2896)

Patient Problems Burning Sensation (2146); Insufficient Information (4580)

Event Type  malfunction  

Event Description

Information was received from a consumer via a manufacturer¿s representative (rep) regarding a patient with an implanted neurostimulator (ins) for urinary dysfunction/sacral nerve stimulation and gastrointestinal /pelvic floor therapy.It was reported that the recharger is not connecting for recharging in some instances.The caller indicated that the patient puts the recharger over the stimulator and it beeps twice and starts to charge.The recharger will disconnect if the patient moves or walks around.The caller indicated that the handset showed that the recharger is charged.The rep had the patient tighten the belt and adjust the position of the recharger on the body.Tech support reviewed considerations for charging.The rep will follow up with the patient and direct them to contact patient services.Additional information was received from the patient.The patient reported issues with the recharger, said that since they received it; it has gradually become worse and it was around the end of march in which patient noticed this change.Patient said that at first would find implant would recharge within 20-30 minutes using the belt over clothes however said now won't recharge through clothes, can't wear the belt and it intermittently beeps when the patient hasn't moved at all and receives error codes (1404 and two other codes) that the rechargerhas stopped working.Patient said that one time recharging it took 2 hours to in crease to 40%.Patient that said that today it took 1.5 hours to recharge from 50% - 90%.Technical services did not ask about the circumstances that led to the reported issue.Reviewed recommended steps to first palpate the area and place over the implant before turning recharger on.Patient said that the ins sticks out so doesn't need to palpate at all, confirmed does feel all sides of the ins.Patient said that it connected right away however after a minute or two said that it has started beeping and hasn't even moved.Patient did turn on the recharger app and said that it was connected and then after a couple of minutes said that received message that ins has fully charged.Based on the information, patient was suggested to perform a reset and to make sure that the programmer is turned off completely before recharges implant next time.Patient will recharge in one week during the day and will call back if issues continue in order to perform additional troubleshooting steps.The patient also requested a smaller belt.No further complications were reported.Additional information was received from a patient and manufacturer representative (rep).It was reported the patient's recharger would be replaced.The wireless recharger was connecting for brief periods of time, then losing connection.No patient harm reported.The patient mentioned that for about a month post-implant, they felt warm internally while charging the ins, but this had gone away with time and they no longer felt heating during charging.A replacement wireless recharger was requested to be sent to the patient.The rep later reported the patient had moved and was unavailable to provide the needed data.The patient called back after receiving the new belt.Patient states the belt is working better for them and they have been able to maintain an ins charging session however it took them about an hour to charge the ins 40% even with excellent coupling.The patient mentioned if they sit, they will lose connection so they stand during ins charging.The patient reported the ins is not deep but does feel like it is sitting at somewhat of an angle under the skin.Reviewed how this may impact ins charging efficiency and that patient may need to apply some pressure to the recharger in order to maintain connection.The patient states they do have an easier time if they hold the recharger and apply pressure.Patient indicated they do not plan on following up with a physician as they have moved, and the r ep told them there is not a doctor within 100 miles of them.Additional information was received from the patient.The patient said the recharger wouldn't connect then all of a sudden it connected and hurt the patient "like you wouldn't believe".The patient took a break then tried again.After 6 tries the recharger connected to the ins and felt like it was burning where the ins was.When this was happening the patient had the recharger in the belt but there was not a thin layer between the recharger and skin.The patient said the ins won't charge with a layer between the recharger and skin.Additional information was received from the patient.Patient stated that the old charger caused shocking not heat that hurts like hell and that they finally sent them a new recharger and the reported issue has improved.No further complications were reported/anticipated at this time.

Manufacturer Narrative

This regulatory report is being submitted as part of a retrospective review as part of remediation plan 411.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
• 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: 18133882
• MDR Text Key: 328246096
• Report Number: 3004209178-2023-21053
• 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: 11/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/14/2022
• Device Model Number: 97810
• Device Catalogue Number: 97810
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/08/2021
• Date Device Manufactured: 11/20/2020
• 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 H10...."
• Patient Sex: Male
• Patient Weight: 70 KG