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

Model Number 3058

Device Problems Display or Visual Feedback Problem (1184); Battery Problem (2885)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/12/2022

Event Type  malfunction  

Event Description

Information was received from a manufacturer representative (rep) regarding a patient with an implanted neurostimulator (ins) for unknown indication for use.The rep reported that patient was implanted last year (b)(6) with her device.She has back problems and needed a urgent mri.We removed the lead on monday (b)(6).The 3058 was plugged and left in the patient, till more clarity.Hcp received the go ahead and we implanted the 978b133 on saturday (b)(6).We connected with the 3058 that was still in the patient.When interrogated with the nvisoin before the procedure there was no serial number, it only gave (b)(4) on the nvisoin.Doing the impedance with the th90p02 during the procedure there was no problem, no impedance and it also gave device ok status.Still did not give a serial number.While still in or i checked if i could activate a program on the device.On the my therapy app it gave me a por (call your clinician)i then interrogated with clinician app and all was fine.Went back in the my therapy app and could activate a program.Checked while still in the or if the device was response and could switch on an go up on stimulation.All was fine and the patient could also feel the stimulation after programming comfortable and as before.No interventions needed to be taken.All is fine, just no serial number.The issue was confirmed resolved.

Manufacturer Narrative

Country event occurred in za.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

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 manufacturer representative (rep).The rep reported that the cause of the por/only gave njy??? was unknown.Rep reported the issue was resolved on the date of implant the 12th of march.The rep had reached out to technical services again inquiring on the th90p02 could not connect with the 3058.I used the nvision to do the impedance check and checked if i could proceed with the th90p02.It seems to have lost the serial number and gave me an option of (b)(6) did respond to (b)(6) and i could program and proceed, but it could not pick up the serial number of the (b)(6).Technical services provided troubleshooting and the rep reported all is fine with the patient, programming and there is no problem.They just did not put in the serial number again and as you said one cannot do it afterwards.Just wanted to know how to trouble shoot on an event like this.In future rep will make sure to get the serial number from the patient before the case.One can also ask the doctor to read it off the (b)(6) that is reconnected to the new 978b128 lead.

• 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: 13892624
• MDR Text Key: 297689564
• Report Number: 3004209178-2022-03729
• 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: Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 03/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/28/2022
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/12/2022
• Initial Date FDA Received: 03/24/2022
• Supplement Dates Manufacturer Received: 03/23/2022
• Supplement Dates FDA Received: 03/28/2022
• Date Device Manufactured: 12/03/2020
• 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 Age: 25 YR
• Patient Sex: Female