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); Failure to Deliver Energy (1211); Device Difficult to Program or Calibrate (1496)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: product id 3037, serial# (b)(4), product type programmer, patient.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 unknown indications for use.It was reported that they haven't been happy with ins "from the beginning" (did not clarify year) and have been having a lot of trouble with it.The patient reported having trouble trying to change the program.They were trying to sync with ins on call and was seeing interstim icon on screen.Confirmed able to successfully sync with ins and stated therapy was off.The patient tried to turn on therapy and was seeing sync screen on programmer.They used programmer a few days ago and it was working.Confirmed using standard (b)(6) batteries in programmer.The patient removed batteries on call to provide programmer sn and confirmed able to successfully turn on therapy following reinserting batteries and could feel stim working.The patient stated stimwas at 1.6v on program 4.They wanted to change programs.Reviewed how to change program and the patient changed to program 1.The patient then stated stim was off.Reviewed how to turn on stim and the patient successfully turned on stim on program 1 at 1.8v.The patient changed to program 2 at 1.9v and confirmed stim felt comfortable.Agent did not ask about the circumstances that led to thereported issue.The issue was not resolved through troubleshooting.Provided education on how to change programs and documented information the patient provided.The following day, the patient called back stating again they are having trouble "programming" it.They were suffering last night, ins is not helping with symptoms and the physician may have ins removed due to this.They will discuss this with their healthcare professional (hcp).The patient can't figure programmer out and are having trouble with it.Provided education on use of programmer (how to sync with ins and change programs/increase stim).The patient is using the antenna with programmer.Reported program 2 at 1.9v is not working.Due to this, the patient wants to change programs.They then stated on call that therapy is off.Reviewed how to turn on therapy.The patient successfully turned on therapy on program 2 at 1.9v.They still wanted to change programs and wanted to try program 3.The patient changed to program 3 at 2.5v.The patient increased stim to 2.6v on program 3 and stated stim felt strong, but it was ok.Reviewed therapy/stimulation expectations.Recommended the patient monitor symptoms and follow up with hcp if still not seeing improvement.

• 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: david gustafson ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635149628
• MDR Report Key: 11393512
• MDR Text Key: 244327202
• Report Number: 3004209178-2021-03418
• 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
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/01/2021

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: 03/14/2019
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/25/2021
• Initial Date FDA Received: 03/01/2021
• Date Device Manufactured: 09/15/2017
• 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