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

Model Number 97810

Device Problems Overheating of Device (1437); Delayed Charge Time (2586); Battery Problem (2885); Charging Problem (2892); Communication or Transmission Problem (2896); Insufficient Information (3190); Audible Prompt/Feedback Problem (4020)

Patient Problems Burning Sensation (2146); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/20/2023

Event Type  malfunction  

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 they used to charge once a week and now they have to charge twice a week.The caller reports no falls or trauma, but that they have had weight loss of 30 pounds and had colon surgery.The patient did increase the stimulation recently to 2.0, around 1 month ago when they noticed the change in recharging.The caller reports the recharger will go from great to good while recharging and if they try to reposition the recharger, it will lose connection and be difficult to get back.They reported that the ins goes from 80% down to 50% quickly.Reviewed with caller to try and maintain excellent connection for fastest recharging.Reviewed at the next appt with the hcp they can pull some additional information if needed to check on recharging specifics.Additional information was received from the patient on 2024-feb-05.They called back regarding recharger.Patient stated they were instructed to call if codes came up on handset while recharging.Patient stated they saw 1707 code and then held down the power button on the recharger and saw "3731" error code agent clarified that code indicated patient to hold recharger power button and was most likely 3701 code, but patient was unsure of last few digits.Patient stated they were seeing excellent connection and charged to 100% during the call.Patient will call back if issue persists.They did called back at 8:26am (b)(6) 2024 from registered number repeating ongoing, intermittent issues with recharging difficulty stating, it just quits, the light goes red and they have been charging twice a week.Sometimes it works and sometimes they can only get 20% then their connection goes from excellent, to good, to fair and quits and they don't move at all, they are always sitting down.Patient said it also charges them more slowly than when they first got it and the beeping sounds fainter than it had previously.Patient said they tried to charge thursday last week and could only progress 20 percent from 50-70.Patient started charging during the call, connected immediately then lost connection, repositioned the charger and connected with an excellent connection.Reviewed some recharging education information and encouraged patient to take note if the handset ever showed any codes or messages.Patient said they were only aware of the charger telling them to call medtronic.Patient was successful to maintain excellent and during discussion connection went to good.Patient repositioned and got an excellent connection to continue charging.During the call the ins battery level progressed to 70, 80, 90%.Patient checked their charging speed and were at fastest and checked their volume (beeping).Patient said they do not wear the belt, they could only get 20 percent with the belt, they hold the charger in their hand and don't even move.Patient said there was a time around christmas (2023) the charger got too warm and they had to quit and start charging again later and it has not happened again.Reviewed since they were successfully charging to continue using the equipment,if they see any codes on the screen to write them down and call pats back for further support.Reviewed they can bring their equipment with them to the doctor for hands on support.Patient said they have an appointment in march but dr doesn't do anything with the equipment.Reviewed the doctor could coordinate the appointment with a manufacturing representative (rep).Patient said they would call the hcp office and try to coordinate the appointment with a rep.

Manufacturer Narrative

Continuation of d10: product id wr9220 lot# serial# (b)(6) implanted: explanted: product type recharger section d information references the main component of the system.Other relevant device(s) are: product id: wr9220, serial/lot #: (b)(6), ubd: , udi#: 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.

Manufacturer Narrative

Continuation of d10: product id wr9220 lot# serial# (b)(6); product type recharger 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

Additional information was received from the patient.They reported that the recharger was not lasting for the full charge.They have called the help line 3 times.They met with their hcp 2024-apr-13 but the rep was a no show.They are able to successfully charge the implant which is at their left hip.They have another appointment on the 18th.Additional information was received from the patient.They reported that the recharger does not stay connected to the stimulator and times out.They had an appointment with the hcp on 2024-03-13 and they both agreed with the previous statement to make an appt with another hcp to talk about a replacement or adjust as is for the year.They are able to charge the implant in their left hip at an unknown depth.The cause of the intermitted communication was determined.Patient was told the early rechargers are acting this way and their recharger was implanted in 2020.(it is assumed the patient is talking about their rechargeable ins).This issue has not yet been resolved.The cause of the recharger issues of quitting, the light going red, and the beeping sound being fainter than it had previously was stated to the ins not the recharger by the previous mentioned reason.This issue is not yet resolved.

• 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: 18735504
• MDR Text Key: 336751452
• Report Number: 3004209178-2024-05160
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 97810
• Device Catalogue Number: 97810
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/05/2024
• 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: 74 YR
• Patient Sex: Female
• Patient Weight: 93 KG