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

Model Number 97810

Device Problems Inappropriate/Inadequate Shock/Stimulation (1574); Battery Problem (2885)

Patient Problems Scar Tissue (2060); Electric Shock (2554)

Event Date 11/21/2023

Event Type  malfunction  

Manufacturer Narrative

B3: date is approximate.Year is confirmed valid.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 via healthcare provider who was implanted with an implantable neurostimulator (ins) for urinary dysfunction/sacral nerve stim, gastrointestinal/pelvic floor.It was reported that patient has been having connection issues with both recharger and communicator for approximately 3 months.Caller stated app isn't connecting to recharger despite rescanning the code and patient stated it is taking longer to connect to ins and disconnecting during to recharging.Patient stated when attempting to use communicator, handset will show "not found" and retry but it continues to say "not found" and can take a half hour to finally connect.Patient also mentioned getting the "all data lost, reboot" screen when they initially power on the handset.Patient also stated that when recharging the ins, they feel like they are being electrocuted at the ins site despite using the belt when recharging.Patient mentioned they have had a lot of interstims, so there is probably deep scar tissue there as well.Tss had caller reset recharger which then gave a descending tone and then powered off.Caller docked and undocked the recharger, turned it on and it successfully connected to ins.Subsequently, the app connected to the recharger as well showing ins was at 50% with excellent connection.Caller stated patient has the older case for the handset where the elastic straps sit against the handset buttons so they already reviewed with patient to ensure the straps aren't positioned directly on the handset buttons.Caller also discussed that they will try adjusting settings for when patient is charging to try and alleviate sensation while charging.Tss reviewed bluetooth connection between app/recharger and app/communicator and that rebooting handset, communicator and resetting recharger may resolve those issues.Patient stated they haven't had any falls/trauma to ins site nor have they seen any specific error codes when using communicator or recharger.

• 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: 18768139
• MDR Text Key: 336987193
• Report Number: 3004209178-2024-05555
• 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,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/23/2024

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: 05/28/2022
• Device Model Number: 97810
• Device Catalogue Number: 97810
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/21/2024
• Initial Date FDA Received: 02/23/2024
• Date Device Manufactured: 12/09/2020
• 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
• Patient Age: 38 YR
• Patient Sex: Female