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

Model Number 3058

Device Problems Failure to Interrogate (1332); Battery Problem (2885); Communication or Transmission Problem (2896); Insufficient Information (3190)

Patient Problems Pain (1994); Dysuria (2684)

Event Date 10/24/2023

Event Type  Injury  

Event Description

Information was received from a patient who was implanted with an implantable neurostimulator (ins) for urinary dysfunction/sacral nerve stimulation and gastrointestinal/pelvic floor.It was reported that the patient's device is not working/they are having a return of symptoms.Patient clarified they are having a little bit of trouble with emptying their bladder.Patient reported when they go to the bathroom it's like they start to pee and then it stops and they start peeing again.Patient stated they don't feel like it's all emptying out like it was to begin with.Reviewed role of patient services and redirected patient to their managing healthcare provider (hcp) to address.Patient will give their hcp a call.Provided event date as they think it has been like 5-6 weeks ago and stated it took a while to get an appointment with their dr (they had appointment today).Patient then reported one night they started feeling a pain that they guess woke them up and they started having really sharp pain down in the bottom of their hip "it was like the stimulator was hitting me really hard." so they got their device and they were able to turn it down at that point but stated when they decreased down to like 1.4 to where they could not feel it "it hit me so hard, then it kicked off." patient clarified by this they mean the screen went blank.Then when they turned back on they saw a picture of a dr with a stethoscope on their programmer screen (patient did not recall any other codes/information on the screen with picture of dr).Patient reported now they can't get this screen back and reported now they are getting the poor communication screen when they attempt to connect with their implant with use of the antenna.Patient confirmed placing antenna directly on implant.Reviewed how to connect with implant using programming by itself and reviewed general use of 3037 programmer.Patient reported continued getting poor communication screen with use of programmer by itself without antenna.Agent reviewed poor communication screen meaning and reviewed eos considerations.Redirected patient to their managing hcp to further discuss.Patient stated their managing hcp thinks more than likely their implant is dead and will need to be replaced.Reviewed process to coordinate appt with rep and provided patient with nas phone number for hcp if needed.Patient inquired if there is an implant system that allows for mris.Agent reviewed general overview of surescan lead system and redirected to hcp/rep to further discuss.Agent did not ask about the circumstances that led to the reported issue.The patient was redirected to their healthcare provider to further address the issue.Additional information was received from a healthcare professional (hcp).When asked to clarify the statement ¿the device was not working¿ the hcp reported the device has a battery that is dead.Therefore it is not working (device failure).Cause of the device not working was determined to be the battery is dead.The device was interrogated and evaluated by the rep.The issue was not yet resolved.The cause of the poor communication message was determined to be a device failure.The plan was to replace the battery but issue is not yet resolved.

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.

Manufacturer Narrative

H6 codes updated to reflect serious injury.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.

Manufacturer Narrative

Continuation of d10: product id: 3037, product type: programmer, patient.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

Event Description

Additional information was received from the patient.They reported that the patient called back regarding previously noted issue with symptoms and replacement.Patient stated they have been dealing with return of symptoms for months and would like to get replacement done soon.Patient stated their hcp told them they needed to have a mdt rep present.Reviewed rep role and patient services role with patient.Provided patient with nas number for hcp if needed and emailed field staff requesting assistance.

• 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: 18456637
• MDR Text Key: 332250407
• Report Number: 3004209178-2024-00301
• 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,Health Professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 04/05/2024

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 Expiration Date: 01/28/2017
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/05/2024
• Initial Date FDA Received: 01/05/2024
• Supplement Dates Manufacturer Received: 01/05/2024; 03/13/2024
• Supplement Dates FDA Received: 01/05/2024; 04/05/2024
• Date Device Manufactured: 08/12/2015
• 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
• Treatment: "SEE H10."; "SEE H11."
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR
• Patient Sex: Female
• Patient Weight: 88 KG