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

Model Number 3058

Device Problems Energy Output Problem (1431); Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Fall (1848); Memory Loss/Impairment (1958); Paralysis (1997); Dysphasia (2195); Unspecified Nervous System Problem (4426); Insufficient Information (4580)

Event Date 04/01/2023

Event Type  malfunction  

Manufacturer Narrative

B2: paralysis 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

Information was received from a patient who was implanted with an implantable neurostimulator (ins) for gastrointestinal/ pelvic floor and urinary dysfunction/sacral nerve stim.It was reported that the device was supposed to be shut off and has reactivated again by itself this past april and is sending impulses in the patient's body and causing neurological issues.Patient said that at first thought they were having blood pressure issues and then started having other issues.Patient said they are experiencing many neurological symptoms similar to a stroke, said they are losing their speech and memory and has also fallen so many times that they can't remember anymore.When asked, patient said that a couple of years ago the device was turned off when patient had another surgery.Patient said that at that time the hcp turned the therapy off, said that it was no longer working and told patient not to put the bat teries back in the programmer.Patient said at that time didn't have medical insurance and couldn't afford to have the system removed.Patient said they were redirected to contact the hcp when able to have the implanted system removed.Patient said due to their symptoms they went to the er on mary 3rd however were told that there isn't anything they can do until the implant is removed.Patient said that again they were told not to put the batteries into the programmer as it may make their symptoms worse and they don't know what the repercussions could be, said that it could shut the patient's heart off.Patient said has had paralysis and everything else.Patient that three doctors and pa from the er has sent urgent messages to the hcp.Patient said that they had spoken to hcp office many times however the hcp will not follow up directly with the patient.Patient said that they would like the implanted system be removed as soon as possible however isn't able to get that arranged with implanting physician.Patient said that yesterday afternoon spoke with a nurse at the hcp office and was told that a message would be sent to the hcp, however the patient hasn't heard anything back yet.Troubleshooting was unable to be performed as patient refused to use the programmer to check therapy status.The patient was redirected to their healthcare provider to further address the issue.Patient was redirected to seek medical attention.Patient again said that the er won't touch her because of the implanted device.Patient said symptoms are getting worse however said needs to have system removed in order to have additional testing performed to determine why the patient is having all these problems.

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 healthcare professional (hcp).The hcp reported that the cause was due to normal battery depletion and that the patient did not have stoke and device was removed on (b)(6) 2023 and issue resolved.Health care professional also stated that the neurological issues were not related to device or therapy.

Manufacturer Narrative

H6: the codes have been updated to align with the new information and the file is now unsupporting the serious injuries previously reported as the hcp provided a response stating they were unrelated to the product and therapy.H3: analysis of the ins (s/n (b)(6) revealed that the implantable neurostimulator (ins) passed functional testing.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

No new information for the event description.

• 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: 17049798
• MDR Text Key: 316398269
• Report Number: 3004209178-2023-08471
• 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,Followup,Followup
• Report Date: 11/07/2023

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: 02/14/2017
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: 05/05/2023
• Initial Date FDA Received: 06/02/2023
• Supplement Dates Manufacturer Received: 06/15/2023; 10/12/2023
• Supplement Dates FDA Received: 07/05/2023; 11/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/21/2015
• 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): Other
• Patient Age: 46 YR
• Patient Sex: Female
• Patient Weight: 79 KG