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

Model Number 3058

Device Problems Migration or Expulsion of Device (1395); Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problems Unspecified Infection (1930); Muscle Weakness (1967); Undesired Nerve Stimulation (1980); Pain (1994); Burning Sensation (2146); Depression (2361); Paraplegia (2448); Ambulation Difficulties (2544); Electric Shock (2554); Unspecified Tissue Injury (4559); Insufficient Information (4580)

Event Date 02/12/2021

Event Type  Injury  

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 by the patient that the device was not helping their symptoms at all and they were in a lot of pain.It was reviewed with the patient how to increase stimulation and the patient was able to increase stimulation to where they could feel stimulation.The agent did not ask about the circumstances that led to the reported issue and the patient was advised that if symptoms didn¿t improve, the patient could increase stimulation more.No further complications were reported at this time.Additional information was received from the patient's advocate and the patient was on the line with them.They requested an email with doctor listings of doctor's that work with medtronic device for the bladder and bowel in their area.Troubleshooting emailed the district manager to call the patient.Patient said the rep is being non-complaint with helping them with their stimulator.Patient has the device for both the bladder and bowel and hasn't gotten any relief of symptoms.Patient saw the doctor three times.Doctor thought it might be gi or ob related and didn't think it was the stimulator causing problems.Patient said the rep was always there at the doctor's appointments and they made the rep aware of their issues.Patient doesn't know the reps name but said they were a female.The rep was made aware of the issues not long after implant.Patient notified them by phone a couple weeks to a month after the surgery.Doctor checked the patient for infection and put them on antibiotics just incase there was an infection.Rep kept going up and down on the range of amplitude and it was painful no matter what the amplitude was on.Even at the lowest level, patient felt like screaming.The stimulator has been turned off for months.The patient has been trying to get a hold of the rep.Patient said they had symptoms within a few days of getting the stimulator: undesirable stimulation, jolting and shocking, felt like fingers were in electric socket, unexplained pain in right arm, unexplained pain and weakness in left leg, suspected tissue damage, muscles kind of tearing away from bone (can visually see), biggest thing is there is burning in their spine, can feel the stimulator in back has moved.No matter what the patient did the pain was excruciating.Patient stated they were worse off then before the implant.Patient gave up that it couldn't be the stimulator.The doctor gave them an antidepressant.Last appointment patient went to was in october.The patient didn't even want to go back because the doctor wasn't listening.Last time patient talked to the rep they said to turn it off and it's been turned off since.Gotten worse since turned off in october: burning up the spine, trouble standing, loss of mobility and use of left leg, and sometimes can't feel leg at all, cold to the touch, don't feel anything.If patient tries to get out of bed have to hop out of bed and on right leg and grab something.Patient stated things were wonderful with the trial.Patient has other health issues requiring an mri and management of spinal issues.Doctor wrote patient couldn't have an mri.Troubleshooting reviewed mri guidelines.Had patient put their device into mri mode and they said it is full body eligible.Patient is concerned because the doctor told them that they couldn't have an mri.Troubleshooting suggested having the mri facility call into technical services.Patient has had more then one doctor demand that it be taken out.Patient had degenerative disc disease in lower spine l4 and l5 before the device implant.Now they have a lumbar spinal stenosis.Been in the er had no feeling from waist down and couldn't w alk.Patient has temporary paralysis at times.

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.

• Brand Name: INTERSTIM II
• 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: 15470271
• MDR Text Key: 300435883
• Report Number: 3004209178-2022-12249
• Device Sequence Number: 1
• Product Code: EZW
• UDI-Device Identifier: 00613994913654
• UDI-Public: 00613994913654
• 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: 09/22/2022

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: 05/28/2022
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/01/2022
• Initial Date FDA Received: 09/23/2022
• Date Device Manufactured: 12/10/2020
• 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): Disability
• Patient Age: 53 YR
• Patient Sex: Female