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

Model Number 97810

Device Problems Therapy Delivered to Incorrect Body Area (1508); Battery Problem (2885)

Patient Problems Undesired Nerve Stimulation (1980); Pain (1994); Peripheral Nervous Injury (4414); Cramp(s) /Muscle Spasm(s) (4521)

Event Date 02/27/2024

Event Type  Injury  

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

Information was received from a patient who was implanted with an implantable neurostimulator (ins) for urinary/bowel dysfunction, urge incontinence.It was reported that they haven't used their therapy in 1.5 years.Patient states they only had it on for a couple months and then it gave them hammer toe and they couldn't figure out what it was so they had it scheduled for surgery to get their tendons cut.Before they realized it was the machine, they were in excruciating pain and all 5 of their toes curled under and eventually gave them something called drop foot.Patient states they met with a representative about a year and a half ago and the representative went through the settings which didn't do anything.Patient states they just decided to have it shut off.Patient services reviewed how to activate mri mode for an upcoming mri on the head due to memory issues.Patient states this started around the same time they got the implant and was curious that could be related.Agent reviewed known adverse events and redirected patient back to doctor.While activating mri mode patient noticed por detected and confirmed they finally charged the device last night.Patient was able to bypass and access mri mode on the call.Additional information was received from a manufacturer representative (rep).The rep reported that they met with the patient on (b)(6) 2022.The patient had made an adjustment to program 4 in which the patient was feeling stimulation in the vagina.The rep was made aware of stimulation in leg which could have caused toe curl if stim was too high.Once they reprogrammed the patient they felt stimulation in their vaginal area.

• Brand Name: INTERSTIM
• 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: 18826417
• MDR Text Key: 336780186
• Report Number: 3004209178-2024-06178
• Device Sequence Number: 1
• Product Code: EZW
• UDI-Device Identifier: 00763000203849
• UDI-Public: 00763000203849
• 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,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/28/2022
• Device Model Number: 97810
• Device Catalogue Number: 97810
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/27/2024
• Date Device Manufactured: 06/30/2021
• 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: 42 YR
• Patient Sex: Female