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

Model Number 97800

Device Problems Break (1069); Electromagnetic Interference (1194); Overheating of Device (1437); Malposition of Device (2616)

Patient Problems Erythema (1840); Pain (1994); Burning Sensation (2146); Fluid Discharge (2686); Swelling/ Edema (4577); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/25/2022

Event Type  Injury  

Manufacturer Narrative

Continuation of concomitant medical products: product id: 978b128, lot#: va2lavx, product type: lead.The main component of the system.Other relevant device(s) are: product id: 978b128, serial/lot #: (b)(4), ubd: 20-jan-2024, udi#: (b)(4).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/bowel dysfunction and urge incontinence.It was reported that on october 25th patient had an annual mri to check on the status of their ms.The device was put into mri mode and patient was put under conscious sedation so they could remain alert during the mri.Patient did not know what scanning conditions were used to perform the mri.Patent reported the ins area was burned during the mri.It hurt when patient got home and thought it was just from laying on it for an hour and a half during the mri but the next morning there was liquid draining from the ins and at first thought it was a pressure sore but it kept getting worse each day and you could see the device and it was red and swollen.Patient had surgery on friday and the surgeon said they had to remove 3 inches of tissue below the ins.Patient provided the following details from the doctor's op notes: device and leads were removed intact.Malfunctioning or heating occurred, and ins became exposed through a 1 cm area due to skin thinning.Linear incision was made over the ins and incorporated the exposed area through the incision and the ins was dissected out entirely.The wiring was stripped from the lead upon attempt to remove it, a second incision was made to remove the lead intact.Ins and lead both removed and were sent to pathology.They also excised the capsule that encased the ins.Patient reported the wound area is 4.2 by 2.8 by 1.8 and they are currently using a wound vac to improve healing.Patient also plans to follow up with plastic surgery to do further repair.Patient was just discharged from the hospital yesterday.Patient stated their managing urologist had never heard of this happening before.Documented reported event.Recommended patient request that surgeon send explanted device for analysis.The call was disconnected.Ps called the patient back and left a voicemail.

Manufacturer Narrative

Upon receipt of new information, it was determined that the information in this mfr report pertains to 2182207-2022-02128.All information in this event and any future new information will be documented and submitted in that report.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 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: 15748711
• MDR Text Key: 303229241
• Report Number: 3004209178-2022-14613
• Device Sequence Number: 1
• Product Code: EZW
• UDI-Device Identifier: 00763000484668
• UDI-Public: 00763000484668
• 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: 11/22/2022

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: 12/14/2023
• Device Model Number: 97800
• Device Catalogue Number: 97800
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/02/2022
• Initial Date FDA Received: 11/07/2022
• Supplement Dates Manufacturer Received: 11/22/2022
• Supplement Dates FDA Received: 11/22/2022
• Date Device Manufactured: 06/21/2022
• 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
• Treatment: "SEE H10...."
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR
• Patient Sex: Female