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

Model Number 3058

Device Problems Migration or Expulsion of Device (1395); Electromagnetic Compatibility Problem (2927); Insufficient Information (3190)

Patient Problems Muscle Spasm(s) (1966); Pain (1994); Discomfort (2330); Sleep Dysfunction (2517); Ambulation Difficulties (2544)

Event Date 05/01/2020

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from the consumer regarding a patient who was implanted with an implantable neurostimulator (ins) for urinary dysfunction/sacral nerve stim and gastrointestinal/pelvic floor.Patient stated that they call because they wanted help turning the device off because they have been to the er twice and can't take the pain anymore.Patient said she can't walk and can hardly get out of bed w/out calling a nurse for help.Pt said she has been taking tylenol but the tylenol is not helping and that the pain started in may but this week the pain has gotten bad and sharp.During the call patient was getting the poor communication on the pp.Patient later stated that they wanted stimulation off turn stim off.But received poor communication with and without the antenna; email was sent an email to repair.The nurse mentions that the patient is due to have the ins replaced at the end of the month due to all of the pain it is causing her.No further complications noted or anticipated.

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.It was reported that the patient have not slept in five nights.The stim is causing her pain.Two people at her house tried connecting the patient programmer (pp) to her ins to shut off the stim.They kept getting poor communication.They cannot feel the ins.Tried explaining where the incision is and where to line up the pp.The patient got a new pp sent to her today.They are moving the pp all around and trying to sync and is getting poor communication.They are not using an antenna.The patient mentioned the old pp did not work either.The caller said the nurse is on her way and they will call when she gets there to turn and turn stim off.The patient and nurse called back to try and troubleshoot the poor communication.Patient services reviewed the information and on the call, the nurse finally found the ins on the left side of the patient's body, not on the right (the nurse and patient did not clarify this).They was able to connect to her settings and see that stim has been off this entire time.The patient wanted to know why she is in so much pain if the device has been off; patient services reviewed information and recommended to seek appropriate medication attention as needed.No further patient complications are anticipated or expected as a result of this event.

Manufacturer Narrative

Continuation of d11: product id: 3037, serial# (b)(6), product type: programmer patient.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.It was reported that the cause of the pain and inability to walk was they tried to change programming and it didn¿t work.They also said that the cause was they were having trouble walking and couldn¿t get comfortable.No steps had currently been taken.When asked for clarification on the pain and inability to walk the patient said the pain is bad and the pain in back and legs, spasms can¿t get controlled.When asked about resolution of the pain and inability to walk they said the device has a default and it has not been resolved.When asked about resolution regarding the ins on left side instead of right they said it has not been resolved.When asked about circumstances that led to the pain the patient said they just started having a lot of pain.They confirmed the pain has not been resolved.They patient planned on taking the device out aug 4th.The patient said that the issue had been going on for a couple months.

• 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
• MDR Report Key: 10227810
• MDR Text Key: 197745357
• Report Number: 3004209178-2020-11532
• Device Sequence Number: 1
• Product Code: EZW
• UDI-Device Identifier: 00613994913654
• UDI-Public: 00613994913654
• Combination Product (y/n): N
• PMA/PMN Number: P970004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup,Followup
• Report Date: 07/27/2020

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: 01/14/2019
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/01/2020
• Initial Date FDA Received: 07/03/2020
• Supplement Dates Manufacturer Received: 07/02/2020; 07/20/2020
• Supplement Dates FDA Received: 07/06/2020; 07/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: "SEE H10...."
• Patient Outcome(s): Required Intervention
• Patient Age: 76 YR
• Patient Weight: 82