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

Model Number 97810

Device Problems Display or Visual Feedback Problem (1184); Migration or Expulsion of Device (1395); Use of Device Problem (1670); Charging Problem (2892); Communication or Transmission Problem (2896); Insufficient Information (3190)

Patient Problems Electric Shock (2554); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/27/2020

Event Type  malfunction  

Manufacturer Narrative

Event date is approximate, the month is valid.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a patient via manufacturer representative regarding a patient who was implanted with an implantable neurostimulator (ins) for urinary dysfunction/sacral nerve stim and gastrointestinal/pelvic floor therapy.It was reported that the¿recharger was shocking the patient during recharging sessions the patient attempted charging over some clothing and over underwear and that did not resolve the issue.The patient did not put the recharger against the skin.The sensation did not occur with the communication with the handset/communicator.The caller indicated that the recharger would find the ins and then it makes the clicking noise and then loses the connection to the ins.The recharger continued making the clicking noise while it tries to connect to the ins.The recharging process takes a long time and generates heat during the charging session.The application showed that the device was charging because the charge level increments upward.The caller also indicated that when they were with the patient they got an error message with code 1707.The caller stated that the ins was not very deep.The caller was not with the patient at the time of the call so no troubleshooting was conducted.The caller wanted to have a recharger sent to the patient.An email was sent to repair for a new recharger, because the recharger was shocking the patient even after the exposed pins were covered.The caller called back on (b)(6) 2021, they wanted it noted that the shocking sensation occurs in the pocket, only while recharging and mentioned discussing the issue with the engineers.On (b)(6) the recharging equipment was replaced and patient stated the recharger had been shocking the patient even after the exposed pins are covered.Additional information was received from a consumer and manufacturer representative (rep).The rep called in with the patient (pt) for troubleshooting a new wireless recharger (wr) that was sent to patient last week.The pt was reporting that the new wr couldn't find the battery.Pt had reported to rep that they was able to feel the ins previously but now seems to not be able to feel it.The rep stated they were going to get a weight on patient to see if that had changed.The rep was reporting seeing a screen that was showing the ins charging but the wr was not over the ins and that they saw 2 wr icons at the top left of the handset even though the 1st wr was boxed up and turned off.Technical services realized that rep was in open loop mode and moved back to the patient.When the wr was over the ins, rep was able to move the wr around and were able to find the spot where the wr found the ins.It would beep, go to green light and click but within 1 min, it would go back to searching for ins.The rep did this for multiple attempts and finally had nurse palpate to locate the ins, per rep it appears the ins moved more lateral to the incision.Once they got the right location, wr was able to find ins and maintain communication with ins and charged it from 10% to 40% while we were on the phone.The rep was able to pull log files and will send them in.They will send the 1st wr with the "shocking" sensation while charging back to mdt for analysis.The rep stated the 1st wr was really bad with shocking but new wr wasn't shocking although they were charging over the t-shirt today.X-rays were ordered to look at ins placement.There were no patient complications reported as a result of this event.

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 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

Additional information was received from a consumer and manufacturer representative (rep).The cause of the patient's difficulty with their second recharger finding their implant determined to be the patient was not aligning the charger over the implant.Regarding the unexpected screen seen: technical support said on the phone it was normal and acting as if it was searching for a depleted ins.No x-rays have been taken.Regarding the ins lateral movement: no steps have or will be taken, the patient is not experiencing discomfort therefore no intervention required.

• 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
• MDR Report Key: 11346092
• MDR Text Key: 233091077
• Report Number: 3004209178-2021-02864
• Device Sequence Number: 1
• Product Code: EZW
• UDI-Device Identifier: 00763000203849
• UDI-Public: 00763000203849
• Combination Product (y/n): N
• PMA/PMN Number: P970004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 04/27/2021

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: 02/14/2022
• Device Model Number: 97810
• Device Catalogue Number: 97810
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/09/2021
• Initial Date FDA Received: 02/18/2021
• Supplement Dates Manufacturer Received: 04/27/2021
• Supplement Dates FDA Received: 04/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 33 YR