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

Model Number 3058

Device Problems Therapy Delivered to Incorrect Body Area (1508); Patient Device Interaction Problem (4001)

Patient Problems Undesired Nerve Stimulation (1980); Pain (1994); Anxiety (2328); Shaking/Tremors (2515); Insufficient Information (4580)

Event Date 02/08/2022

Event Type  malfunction  

Manufacturer Narrative

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 unknown indications for use.It was reported that  with permanent yesterday and having less leakage but more than with trial.Pt reports is concerned about feeling a "tremor" down left leg and into foot that started yesterday but has gotten worse throughout the night.Pt reports decreased stimulation but still having tremors.Pt reports nurse stated pt did best on programs 2,3, and 4.Pt switched to program 3 and felt stimulation in the thigh but that traveled to calf and toes when pt bent down.Pt then changed to program 4 and felt stimulation in the leg.Pt then switched to program 5.Confirmed stimulation in the bicycle seat area and comfortable.The patient will maintain a stimulation level and will continue to track symptoms. the patient called back and repeated information about tremor/stimulation going down the leg (see listed below).The patient said is currently on program 5 at 0.6 and is still feeling the tremor in her leg but not as strong, it is more like a "shaky" feeling.The patient did comment that today her symptom control is a little better.Reviewed therapy expectations including healing time factors and reviewed general programming guidance.The patient to consider decreasing the setting on the current program to 0.5 and determine what is felt in leg and if symptom control gets worse to consider switching to a program that hasn't been tried yet and try remaining programs as needed.The patient was redirected to monitor and track and provide updates to hcp at her follow-up appointment which is next week on friday.  no further complications were reported/anticipated at this time.

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 the patient.Asked if the cause of the stimulation down the leg was determined, they stated kind of.They stated where the stimulation is sending a signal is next to the nerve for their toe and leg.The sharp pain is less finally, but the jittery/restless feeling continues.They stated they met with the pa twice, they tried adding 2 new programs but failed because they completely lost control.They said they were being dramatic and gave them more time to heal.They stated they are currently not seeing the minimal 50% improvement as they did with the trial and they are frustrated and expected better.

• Brand Name: INTERSTIM II
• 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: 13552656
• MDR Text Key: 286668201
• Report Number: 3004209178-2022-02207
• Device Sequence Number: 1
• Product Code: EZW
• UDI-Device Identifier: 00763000449711
• UDI-Public: 00763000449711
• 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: 04/08/2022

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: 03/28/2023
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/09/2022
• Initial Date FDA Received: 02/17/2022
• Supplement Dates Manufacturer Received: 03/18/2022
• Supplement Dates FDA Received: 04/08/2022
• Date Device Manufactured: 10/01/2021
• 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 Age: 43 YR
• Patient Sex: Female