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

Model Number 97800

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Foreign Body Reaction (1868); Incontinence (1928); Unspecified Infection (1930); Pain (1994); Discomfort (2330); Insufficient Information (4580)

Event Date 09/11/2023

Event Type  Injury  

Manufacturer Narrative

B3: date is approximate.Month and year are confirmed valid.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 urinary dysfunction/sacral nerve stim.It was reported that the ins has started to come out of the stiches.The patient stated it is now sticking out pretty far and hurting like heck.The patient stated that they went to see their managing health care provider (hcp) on (b)(6) 2023 and they had started leaking again the day before (the patient stated the therapy had helped them a ton to start) and that they told the hcp but they checked it as said "it looks pretty good," however the patient stated it still felt "pretty raw" where the surgery was supposed to "be mending" but then they went to visit a friend in iowa and then came to california and the patient stated it felt like it had to have been how it was implanted because when they moved to get up in bed it felt where the pocket was it was "ripping" when they sat up and it stung like it was ripping open and it started to gradually open up further and further.The patient stated even before it started to happen the patient asked their doctor if the body could reject things because they knew in some cases the body re jects stuff but now they thought that their body was actually rejecting it.The patient stated their daughter looked at the site when they were in ca and told the patient "mom you've got an infected scab and i can see the device sticking out".The patient stated their daughter took them to the hospital at that point and it took 10 hours to have them take a look at things on (b)(6) 2023 but the doctors at the hospital said they weren't specialized to do anything about it and just circled it and told the patient to follow up with their managing health care provider (hcp).The patient stated they gave them antibiotics to take because the patient stated it was infected.The patient stated they didn't know what to do and that it hurt so bad.The patient stated the therapy had really helped so they knew they want to try again if the device had to be removed because they "needed it." the manufacturing representative was notified of the situation, advised them to go back to their hcp and the patient was also advised to go to the hospital in the case of an emergency.

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 healthcare professional.It was reported that the cause of the device coming through the skin was unknown.Hcp stated patient was morbidly obese and has reduced mobility, making it likely there was a lot of friction at the implant site.It is unknown if issue has been resolved.

• Brand Name: INTERSTIM X
• 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: 18273645
• MDR Text Key: 329827308
• Report Number: 3004209178-2023-25248
• Device Sequence Number: 1
• Product Code: EZW
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 02/12/2024

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 Model Number: 97800
• Device Catalogue Number: 97800
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/04/2023
• Initial Date FDA Received: 12/06/2023
• Supplement Dates Manufacturer Received: 01/24/2024
• Supplement Dates FDA Received: 02/12/2024
• Date Device Manufactured: 06/02/2023
• 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): Required Intervention
• Patient Age: 61 YR
• Patient Sex: Female
• Patient Weight: 117 KG