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

Model Number 97810

Device Problems Electromagnetic Compatibility Problem (2927); Appropriate Term/Code Not Available (3191)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

B3: event date is not known.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 dysfunction/sacral nerve stim, gastrointestinal/pelvic floor.It was reported that they have been having some issues with electromagnetic interference where they are "literally picking up like sounds through like tv and stuff".Reviewed role of patient services and redirected pt to their managing healthcare provider to discuss.Pt stated the physician that implanted their interstim device is retired so pt has had no contact with a physician for their interstim implant.Emailed pt physician listing per pt's request.Pt stated their doctors always explained to them that their stimulator and pain pump (pt confirmed right now only talking about their stimulator) are a "closed network" meaning that they could not connect with their implant with cell phones and could only connect using another [manufactures device] device.Reviewed general overview of connecting with pt's implant.Pt reported their problem is that "my equipment is now connecting to other devices".Pt clarified by this they mean they can find their interstim, can "pull it up" and connect with it on their personal cell phones.Pt stated this is also occurring with use of computers now too.Pt stated they are connecting to their implant on these devices through bluetooth.Reviewed overview of interstim micro my therapy app to connect with pt's implant.Reviewed general use of external devices.Pt understood that the micro my therapy app could not be downloaded on personal devices.Pt stated it wasn't until like 6 months ago that their device would ever show up on personal devices.Pt clarified "it's showing up my serial number, my bluetooth, it's the interstim".Pt clarified their implant serial number is showing up under bluetooth.Pt stated they have done as much research as they can "and it's all come back to hey, this bluetooth is your interstim".Reviewed overview of external devices/connecting with pt's implant and redirected pt to healthcare provider to further discuss.Pt stated they have done research that "ethical hackers have shown that these medical devices are very easily accessible that it doesn't take much".Pt stated they have their interstim implant turned off now because they are afraid of this.When agent asked for event date pt stated "being able to like have a personal cell phone connect to it, now i can't use it because i haven't downloaded, but it's showing other apps like medical device apps are able to connect to my interstim and supposedly be able to control it".Pt clarified event date as about 6 months ago" (did not confirm year).Please note, agent had a very difficult time following pt throughout call and made best attempt to document all relevant event information.

• 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: 18013020
• MDR Text Key: 327254932
• Report Number: 3004209178-2023-18438
• 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: 10/26/2023

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: 01/28/2022
• Device Model Number: 97810
• Device Catalogue Number: 97810
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/24/2023
• Initial Date FDA Received: 10/26/2023
• Date Device Manufactured: 07/28/2020
• 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 Sex: Female