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

Model Number 97810

Device Problems Migration or Expulsion of Device (1395); Incorrect, Inadequate or Imprecise Result or Readings (1535); Unstable (1667); Delayed Charge Time (2586); Malposition of Device (2616); Battery Problem (2885); Charging Problem (2892); Communication or Transmission Problem (2896); Positioning Problem (3009); Insufficient Information (3190)

Patient Problems Pain (1994); Weight Changes (2607); Cramp(s) /Muscle Spasm(s) (4521)

Event Date 08/29/2023

Event Type  Injury  

Event Description

Information was received from a patient with an implanted neurostimulator (ins) for urinary dysfunction/sacral nerve stim and gastrointestinal/pelvic floor therapy.It was reported that the patient noted difficulty charging the ins.Patient said that received the replacement recharger and has used it twice as recharges every two weeks.Patient said that they started a recharge session last night however said that the experience was terrible.Patient said that they charged up all of the external components and checked ins battery status prior to starting the recharge session and said that it was at 40% which is typical.Patient said when connected received the recovery mode screen and showed excellent connection however didn't display the actual insbattery percentage.Patient said that they repositioned the recharger over the site and then reset both the recharger and the handset.Patient said that they worked on this for two hours and said that it normally only takes about 30-40 minutes.After two hours patient checked the ins battery status and it still showed as 40%.Patient then mentioned that one night in may experienced a very sharp pain when they turned while sleeping which lasted a few moments and then subsided.The following troubleshooting shooting steps were performed: palpate ins site and patient said can only feel one corner and their husband said only feels two sides.Place recharger over ins site, turn recharger on and then open recharger application.Patient said the recharger recovery mode without the numbers and after repositioning several times did received the open loop screen with numbers and the further to the left and down the higher the numbers became.Patient said that received the good and sometimes excellent connection however still no ins battery status.Patient decided wanted to check ins battery status so stopped recharge session and connected using the communicator and ins battery at 50%.Troubleshooting steps did not resolve the issue.Redirected patient to schedule an appointment at managing physician's office for ins device check.Email was sent to representative notifying them of the patient situation.Additional information was received from a manufacturer representative (rep).The rep reported that the patient started having sharp pain while patient was sleeping in may and was able to charge her implant up until august.Caller reported that the patient was seen by their doctor today, mdt rep was not there.Caller reported ap/lat x-ray was ordered for tomorrow to check for possible flipped or moved ins.Caller reported patient also indicated they had gained 15 lbs this summer.Caller reported physician mentioned, they were able to connect to ins with excellent coupling for less then 5 minutes and the ins did not obtain any charge level.Caller reported patient was also getting in/out of coupling at home.Caller reported physician also checked impedance and all were within normal limits.Caller does not know if physician had assessed the ins pocket site, unknown if ins is deep.Additional information was received from the patient.They reported that after they did some manipulation with the recharger and got it to charge their ins on friday last week, they were able to charge their implant in the "normal" amount of time, about 40 minutes, and it charged from 40%-90%.Two days ago, patient said they decided to check their ins battery percentage and when they tried to charge it again, they saw the open-loop charging screen rather than the battery charging screen.Patient said eventually they were able to see that from friday last week to tuesday this week, their ins battery only dropped from 90% to 80%.Patient said they had their recharger placed in the same spot during the open-loop charging, said it had a good/excellent connection and said they never saw the screen that said their battery and percentage of charge.Patient said they kept it in place for 30 minutes and the screen never changed out of open-loop.Patient said they saw their hcp last week, maybe wednesday or thursday, and when the hcp connected the recharger to patient's ins, they also incurred open-loop charging.Hcp ordered an x-ray to check patient's ins placement and said they wanted to check the positioning to see if it shifted.Patient said they are able to feel a corner of the implant and the hcp said they could feel the bottom edge.Patient said when they were viewing the x-ray during the test, they saw that the battery was not parallel and the battery goes from outside of their butt at a 45 degree angle to their spine.Patient said they are still waiting on the x-ray results.Patient referenced this case and asked if there were any other troubleshooting steps, they could take to connect to their ins easier/better.Reviewed information and patient confirmed troubleshooting steps were taken with ps during the last call (this case).Patient wanted to make sure this was documented.Ps documented information.Patient called back in and repeated the same info about getting the "loop" screen.And taking a long time to charge.They are still experiencing the same issues.They are waiting to hear about the results of the x-ray from the doctor.The caller reports that they have turned down the stimulation so they can try to preserve the battery.The caller reports experiencing error codes intermittently but couldn't recall exactly what they were and mentioned various numbers like 1701, 4101, 4102, and "fourteen something".Reviewed with the caller that we have already replaced the recharger to rule that out.The caller reported that they did have a 15 pound weight gain.The caller reports that they think the device has possibly shifted.Reviewed different recharging positions to help make the connection.The caller reports no other implants near the device.They have titanium, but it in the mouth.The caller reports that they have to push so hard when charging that it hurts their hands and the hands cramp.They also have had hand surgery and have nerve damage in the hand and this is not good for the hands.Encouraged the caller to reach out to the hcp for the results of the x-ray that was taken on (b)(6) 2023.The caller reported that they had reached out to the rep, but they had redirected the patient to "call medtronic to make sure it is documented ".Additional information was received from a manufacturer representative (rep).The rep reported that the hcp determined the ins was likely tilted and not very superficial in the pocket and ultimately decided to replace the ins today.New ins serial number and wr9220 serial number are in secure note and being sent back for analysis.Mdt rep reports that the new ins appears to be charging without issue.Email sent to mdt rep with rpa address and rtg case number.

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 have not 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

Additional information was received from the patient.The patient called to report they underwent ins replacement and the doctor implanted a new 97810 in a different location.This resolved charging difficulties and patient was able to charge ins easily within a half hour.

Manufacturer Narrative

H3 product analysis analysis information pli# 10 product id# 97810 below is unedited, system generated text based on the analysis finding code(s).The returned device was subjected to a series of standard tests that include but is not limited to visual inspection, output and telemetry testing, and functional testing.The returned device passed all testing in the laboratory and no anomalies were identified.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 INCONTINENCE
• 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: 17817637
• MDR Text Key: 324257347
• Report Number: 3004209178-2023-16502
• 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,Followup
• Report Date: 10/20/2023

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: 06/28/2022
• Device Model Number: 97810
• Device Catalogue Number: 97810
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: 08/30/2023
• Initial Date FDA Received: 09/26/2023
• Supplement Dates Manufacturer Received: 09/26/2023
• Supplement Dates FDA Received: 10/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/13/2021
• 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 Outcome(s): Required Intervention
• Patient Age: 75 YR
• Patient Sex: Female